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1. Quality assurance resume - Posted by Anupriya Niranjan

KRANTHI XXXX
Mobile: 079********
Mail: Kranthi******@gmail.com

PROFESSIONAL SUMMARY

- Working as a QA Executive since September, 20XX till date.
- Experience in issuing of line clearance at every step of batch manufacturing
- Done a part time job in my holidays which involved doing promotional events throughout the city for various brands such as XXXX.
- Hands on performing in process quality assurance checks for tablets, capsules and liquid orals.

QA resume
QA tester resume
QA engineer resume
QA manager resume
QA analyst resume

Technical Skill:

-Operating System: Windows 2000, Xp.
- Applications: Ms–Office, Adobe Photoshop.

Personal Qualities:

- Quick Learner.
- Positive Attitude.
- Good Interpersonal and Team skills.
- Excellent communication skills.

Key Responsibilities Handled:

- Performing inprocess quality assurance checks for tablets, capsules and liquid orals.
- Issuing of line clearance at every step of batch manufacturing.
- Maintaining and updating the Batch Manufacturing Records.
- Documentation of log books, caliberation records, temperature and humidity records etc.
- Assisted in production of various products.

Key Projects Undertaken

- Project1: XXXX

Duration: Aug 20XX-May 20XX
Role:
Issuing of line clearance at every step of batch manufacturing.
Maintaining and updating the Batch Manufacturing Records.

-Project2: ABC
Duration: Jun 20XX-Feb 20XX
Role:
Performing inprocess quality assurance checks for tablets, capsules and liquid orals.
Issuing of line clearance at every step of batch manufacturing.
Maintaining and updating the Batch Manufacturing Records.
Documentation of log books, caliberation records, temperature and humidity records etc.
Assisted in production of various products.

Achievements

- Trained X new employees in 20XX.
- Presented at ABC conference.

Employer

- M/s. ABC DRUGS LIMITED,
Working as an QA Executive since September, 20XX till date.
ABC is a professionally managed, well established Public Limited Company, engaged in the manufacture of Pharmaceutical Formulations (tablets, capsules and liquid orals). A WHO cGMP certified Company with a full fledged Quality Control Laboratory and a well designed Quality Assurance Program.
- M/s.XYZ PHARMACEUTICALS: Worked as an QA Executive from June 20XX to Aug 20XX

Academic Qualifications:

- M.Pharma(20XX-20XX) from University2, with aggregate of 86%.
- B.Pharmacy (20XX-20XX), from University1 , with aggregate of 70%.
- Intermediate from CBSE Board (20XX-20XX) with an aggregate of 72%.
- S.S.C. (20XX) with an aggregate of 75%.

Extra Curricular Activities:

- Organized ABC-XX, an inter-collegiate fest in the month of February, 20XX hosted by XXXX College and has been awarded as the Best Event Organizer.
- Organized GHT-XX, an annual fest in the month of January 20XX.

Personal Details:

Date of Birth: 20-05-19XX
Language Known: English & Hindi

2. Quality assurance resume - Posted by Rahul Bhardwaj

Nisha XXXXXXX
E-mail : nishu*******2@gmail.com
Mobile : +91-98**********,
+91-860*********

Career objective

Seeking assignments in Commissioning / Production Management /Quality Management with an organization of repute preferably in Automobile Industry

Academics

-B.Tech in CSE from XXXXXXXXXX in 2008.
-12th from XXXXXXXXXX School in 2004 with 64% marks.
-10th from XXXXXXXXXX in 2002 with 77% marks.

Executive Summary

-A competent professional with over 3.9+ yrs of experience in Quality Assurance department.
-Presently designated with XXXXX Solutions Ltd,Pune,as a Engineer - Quality Assurance.
-Well versed with the concepts of SPC, TS 16949, PPAP, FMEA, and 8D.
-Attended training on 5'S, in XXXXX Technologies.
-An effective communicator & team player with strong analytical, logical, problem solving abilities.

Total Organisational Experience(3.9+ yrs.)
Since FEB'12- XXXXXXX Solutions Ltd. Engineer - Q.A(LPDC)

- XXXXX group is a consortium of companies involved in Design, Engineering and Casting of Aluminum Components with foot prints in India, Europe and USA.
-India Group Sales USD 100 million & EURO 20 million installed capacity in Europe.
-Manufacturer of Cylinder Heads for Passenger cars,four stroke 2/3 wheelers, intake manifold etc with major customers Tata Motors, Maruti Suzuki ,Honda, Bajaj, HMSI, Toyota etc.

Key Result Areas:

Quality Assurance
-Responsible to first piece and last piece approval in line inspection for PDC components.
-Conducting the In Process inspection for the same.
-Conducting Die correction for any non conformity found in the casting.
-To do why- why and root cause analysis for the problem and rejection coming on line.
-Responsible for Final Inspection Stage (PDI).
-Conducting Product Audit. Process Audit to reduce non-compliances & achieve customer satisfaction.
-Conducting inspection & testing.
-Maintaining documents as per TS-16949 and PPAP.
-Carrying out 5S ,Poke- Yoke and kaizen activities for continuous improvement

Projects

-Effective coordination with CFT members to Solving Quality related problem.
-Monthly Pareto analysis & work on projects to reduce PPM.
Previous Organisation:

Since Jan '09 0.00mm;XXXXXXX PVT Ltd”,as a Engineer-Q.A.

- ISO/TS 16949:2009 certified manufacturer of Aluminum Pressure & Gravity Die-casting Components for Two Wheelers.
-Passenger cars with major Customers like GENERAL MOTORS, HONDA,MARUTI,SONA KOYO,SUZUKI,TATA, DENSO,NISSAN RENAULT etc.

Industrial Training

-45 days training at “XXXXXXXXXXX”, Gurgaon. After 4th semester.
-45 days training at “XXXXXXXXXXX”, Gurgaon. After 6th semester.

Skills

-Knowledge of SPC, PPAP, FMEA & 7 QC Tools.
-Knowledge of Profile Projector.
-Good Knowledge of CMM.
-Familiarity of the various processes involved in manufacturing/ production.
-Courses attained for AutoCAD & Pro-E from CADD Center, Gurgaon.
-Knowledge of CNC Programming.

Achivements

-Got Feather in My Cap award for Good Performance
-Got Hats OFF Award for my Punctuality

Personal Dossier

Date of Birth :
Languages known :
Maritial Status :
Hobbies :
Permanent Address :

3. Quality assurance resume - Posted by Swati Das

RUPAK XXXX
Mobile:094XXXXXXX
Email:rupakXXXXX@gmail.com

OBJECTIVE:

Seeking middle level assignments in Quality Assurance (QA) with a growth oriented organization.

PROFESSIONAL SYNOPSIS:

-A dynamic professional with 4 year of experience in Quality Assurance, performance appraisal, attendance, Coordination, Public Relations, General Administration and Personal Management.
-Proficiency in handling day to day Line Inspection activities in coordination with internal departments for smooth business operations.
- Effective Communicator with the ability to relate to people across hierarchical levels in the Organization.

Software Skills:

-MCSA (Microsoft Certified System Administrator)
-MCP (Microsoft Certified professional)
-Hons. Diploma in Software Management (1 Year Course)
-N+ (Networking)
-Windows 98,XP, 2000,2003
-Designing Tools: Auto Cad 2004
-Other: Internet Accessing & E-Mail Handling

Work Experience:

-Organization :XXXXXX PVT. LTD.
-Designation :Quality Assurance

-XXXXX Pvt. Ltd.is Sheet Metal Pvt. Ltd. Company, this company manufacture job such as Long member, Cross Member, brackets, Gassets, Front Net, Rear Hing etc for Tata Motors.
-This Is ISO certified Company.

Responsibilities:

-Daily Activity Report
-Line Inspection
-Incoming Inspection
-Outgoing Inspection
-Manage Contractor’s File
-Manage Daily Activity, Incoming And Outgoing files

-Organization :XXXXXX INDUSTRIES.
-Designation :Quality Assurance

-XXXXX Industries:-It’s a Small Scale Industries Rework of jobs, Fabrications, maintains and job manufacturing Done here.
-It provides manufacture jobs for Tube Division, Caparo, RSB Transmission, and some other plants.

Responsibilities:
-Daily Activity Report
-Line Inspection
-Incoming Inspection
-Outgoing Inspection
-Row Material’s inspection
-Manage Daily Activity, Incoming And Outgoing files
-Cleaning Spatter’s
-Checking Welding Missing Or not
-Job Properly Done as per Drawing

-Organization :XXXXX MOTORS PVT. LTD.
-Designation :Quality Assurance

-XXXXX Motors Pvt. Ltd.:-Basically It’s a Body Buildings Company is an ISO Certified Plants, And it works for TATA MOTORS.
-All parts of Hyva body Like Floor, Side Board, Tail Door and head board make hear. And all fitments part fit here.

Responsibilities:
-Daily Activity Report
-Line Inspection
-Outgoing Inspection
-Row Material’s inspection
-Cleaning Spatter’s
-Checking Welding Missing Or not
-Checking gap between two body runner
-Checking Welding Thickness not less then 4mm
-Job Properly Done as per Drawing
-Row material inspection

-Organization :XXXXX COMPONENTS Pvt. Ltd
-Designation :Quality Assurance

-XXXXX Components Pvt. Ltd.:-Basically It’s a Body Buildings Company Based At Gamharia.
-All parts of vehicles Model No. 1616, 1618 fitment done here in body Like Floor, Side Board, Tail Door and head board make hear.
-And all Bought out items fitments here.

Responsibilities:

• Daily Activity Report
• Line Inspection
• PDI Report
• Row Material’s inspection
• Cleaning Spatter’s
• Checking Welding Missing Or not
• Checking gap between body runner & Subframe
• Checking Welding Thickness not less then 4mm
• Job Properly Done as per Drawing

KNOWLEDGE OF MEASURING INSTRUMENTS:

-Vernier Caliper
-Micrometer
-Height gauge
-Go No Go Gauge
-Radius Gauge
-M-Tape

Education:

-Diploma in Mechanical from XXXXX Polytechnic with 1st division
-B.Com From xxxx University, With II nd Division
-I.Sc From xxxxx Intermediate Education Council (J.I.E.C) Ranchi with 2nd Division sion
-Matriculation From XXXXX Secondary Examination board(B.S.E.B), With 1st Division

Personal Profile :

-Date of Birth :
-Languages Known :
-Contact Address :

4. Quality assurance resume - Posted by Sonali Taste

NSK
91 89********
Ndj_26@gmail.com

Objective:

Seeking Managerial Profile-Quality Assurance at a reputed Manufacturing Organization

CAREER SUMMARY

-Result oriented & detail conscious, offering 4 years experience in Consumer Durable Industries managing Quality Assurance and Operations Management
-Leading New Product Development and project management.
-Achieved high productivity and quality, made optimum utilisation of available resources (men, material & machine).
-Certified : Green Belt Six Sigma
-Proficient in maintaining proper quality standards and ensure operational effectiveness of equipment.
-Possess sound interpersonal & effective communication skill

SKILL AREAS

-Quality Assurance
-Quality System
-New Product Development
-Supplier Quality
-Operations
-Vendor Development
-QMS, EMS & AS9100
-Imparting Training
-Six sigma techniques
-Customer support
-Testing/Inspection

WORK EXPERIENCE

Working as Manager- Quality Assurance at NDY Ltd.
(Jan 2008 – till date)

-Reporting to R&D Head. Handling a team of six employees in quality assurance department and supervised their work.
-Responsible for generating new strategies and plans for improving quality of the product.
-Improve Key Performance Indicator including Incoming inspection, In-process inspection and Final product through various improvement initiatives and living Quality Management System.
-Conducting periodical Quality Audits at Vendor’s place & implementing SPC techniques.
-Minimizing the Inward Quality inspection by implementing the Self Certification process for selected Vendors.
-Evaluation of New developed Samples & Approvals.
-Handled customer queries to meet their expectations.
-Analysis of customer complaints.
-Implementation of corrective actions and monitoring effectiveness.
-Improve customer satisfaction with respect to product quality.
-Reduction of Internal rejection through QC Tools (also with advanced quality tools).
-Analyze and solve problems using PDCA, G-8D, DMAIC methodologies.
-Work with Production personnel in an advisory role to assist them with quality issues within their department.
-Preparation of ISO Documentation procedures, manuals, standards and specifications.
-Handling of internal and external calibrations of instruments and equipments.

Worked as Asst. Manager QA at NSK Pvt. Ltd.
(May 2006 to Dec 2008)

-Improve companywide Quality including Incoming inspection, In-process inspection and Final product through various improvement initiatives and living Quality Management System.
-Conducting periodical Quality Audits at Vendor’s place & implementing SPC techniques.
-Analysis of customer complaints through CAPA & 8D approach. Implementation of corrective actions and monitoring effectiveness.
-Reduction of Internal rejection through QC Tools.
-FOR & CPPM improved by using Quality Tools & special Techniques.
-Identifying deviations, areas of non-conformance & undertaking relevant modifications.
-Executing cost saving techniques/measures & modifications to achieve substantial reduction in O&M expenditures/gross margin targets
-Training to executives on: MSA, Advance quality tools, Problem solving techniques, QMS & EMS awareness training, product training area wise, Lean manufacturing, 5S, reporting techniques, Vendor rating.
-Analyze and solve problems using various methodologies.
-Establish production processes capable of meeting Process Capability (Cp) and Process Capability Indices (Cpk) targets set by the 6-Sigma Performance
-Preparation of ISO Documentation procedures, manuals, standards and specifications.
-Internal Management Representative for QMS & EMS.
-New Products Development.
-Evaluation of New developed Samples & Approvals.
-Problem Analysis, Problem Break Up, Data Collection, Data Analysis and Solution implementation by six sigma approach. Developing and completing departmental targets for six sigma projects.
-Prepare B.O.M of new products. Maintain B.O.M of all products. Ensure B.O.M accuracy at commencement of new products and maintain BOM ACCORACY continuously thereafter.
-Design and implement the manufacturing processes activities, including manufacturing workstation, layouts, jigs/fixtures/gauges/tools/equipment, applying the principles of 8 types of wastes to minimize waste in the manufacturing cycle time, minimize/optimize/manufacturing cycle time.
-Prepare and maintain the work distribution documentation (Operations Manual) of production activities (Sun-Assemblies., main assembly, inspection, testing, packing), Floor-Plan Layouts.
-Train production persons on the manufacturing processes.

Achievements

-Improve Plant by using Quality techniques.
-Improve OQC CPPM from 1300 to 900 PPM.
-Improve FCR from 10% to 7.5 %.
-Self certification of some critical suppliers by regular supplier QMS audits and follow-ups.
-Formation 4 Quality Pillars in Plant (DQ, IQ, SQ, and CQ).
-Successfully Introduce & Produce 2 new product with full proof methods.

Worked as an Executive Quality Assurance at NKS CO.
(Feb 2004 – May 2006)

-Reporting to the Sr. Manager Corporate Quality, leading a team of 9 members and handling Vendors Quality, Inward Quality, process Quality, Final Quality, and Vendor Development & New Product Development
-Approving incoming material from vendors on quality of components, interacting with vendors/plant for improvement in quality, maintain quality inspection records from vendors /Plant.
-Handling new product development; maintaining best quality with minimum rejection. Improving product quality at vendor’s end by undertaking projects,
-Establishing quality standards; implementing QC systems to enhance quality of products; conducting tests & inspections, ensuring operational effectiveness of equipment. Identifying deviations, areas of non-conformance & undertake relevant modifications.
-Implementing cost saving techniques, measures & modifications for substantial reduction in O&M expenditure and facilitate in meeting organisational targets.
-Handling total inspection of export orders, maintain inspection and tests statistics. Coordinating with R & D for new product developments and manage quality related data.
-Integrated Management System – responsible for implementing the requirements of Quality Management System, BIS Certification and environment management system.

Professional Affiliation

-Member of LEAN Journey
-Member of new supplier selection & approval team
-Coordinator for plant Quality circle

Achievements

-Reduce incoming rejection of critical components from 2.5% to 1.5%
-Self certification of some critical suppliers by regular supplier QMS audit
-Formation of Quality circle in the plant
-ISO & BIS certifications

ACADEMICS:

-B.Tech (Electronics & Communications) from SBJ University with Second class.
-HSC (Science) from SND Board with First class.
-SSC from PDS Board with First Class.

OTHER QUALIFICATIONS

-Lead Auditor QMS Certified
-Lean Management Techniques Certified
-Environmental Management System

PERSONAL INFORMATION

Date of Birth:14-08-19**
Languages known:English,Hindi & Marathi
Address:44, B Wing, Anandnagar,MSK.

5. Quality assurance resume - Posted by Sonali Taste

EQI
91 901914****
eq_321@gmail.com

Carrier Objective:

-To work in a renowned professional organization where my skills and abilities shall be put into test for achieving my personal and organizational objectives.

Educational Qualification:

1) Bachelor of Mechanical Engineering from ABC University.
2) Diploma in Mechanical Engineering- from ABC University.

Experience Summary:

-9 years of extensive work experience in the field of Quality control and Supplier Quality Assurance.

WORK EXPERIENCE:

1. Presently working in BPT PVT LTD. As an Asst.Manager-Supplier Quality Assurance since (Mar’2009 to Till Date).It is one of the leading Safety system manufactures in the Automobile Industry. Products like Seat Belt, Steering Wheel and Airbag for all major OEMs in India.

Job Responsibilities,

-Effective management / Processing of APQP stages & PPAP Submission.
-Perform Supplier Quality Systems & Processes Audit at supplier’s work.
-Communicate & ensure adherence of quality requirements to suppliers.
-Interact routinely with Purchasing, Engineering & Suppliers to proactively improve .quality of parts.
-Monthly reporting of PPAP & Audit result status
-Continually work with suppliers to improve performance, implement process control.
-Responsible for investigating, analyzing & solving the problems in part quality at .supplier's works.
-Analyze supplier capabilities, develop & maintain supplier quality PPM within targets.
-Identify potential quality risk & take effective actions to eliminate.
-Manage Low performing suppliers, Non-Conformity Inspection & 8D Reports.
-VA/VE activity.
-Monthly reporting of Supplier PPM & Action Plans.
-Assist in Supplier Evaluations, disqualification & resourcing.
-Ensure compliance of quality system processes - Both at supplier’s works & within the department.
-Continual involvement in improving product quality, reliability & reducing part cost.

2.XYZ PRIVATE LTD-(Sept’2003 to April’2010) worked as a Supervisor-Quality Assurance.It is one of the leading group of companies.It is a joint venture company of which do supplies welded sub assemblies for frame (Co2 welded and Spot welded), P.K.B, Brake,clutch pedal assy, Press parts(Under & Outer Body panels) and spot welded sub assays (center body pillar, Front body pillar, Lower back, and Rear floor side) for TYU Motors India Pvt Ltd. Which do manufacture a popular cars.

Job Responsibilities:
-Conducting Supplier meet to review the performance in Quality, Safety, and Delivery --& to explain the requirement of the company.
-In-house Quality system audit & Supplier Quality audit
-Internal Auditor for ISO/TS 16949:2008.
-Visiting to customer plant and suppliers regarding quality issues & Process validation.
-Periodic review of MQC, PPAP, MSA, SPC & P-FMEA to assess adequacy of controls.
-Follow up on supplier corrective action.
-Approval of part development process at supplier end.
-ECI (Engineering Change Information) implementation and taking approval.
-Training and educating the team members.
-Promoting QUALITY CIRCLE, KAIZEN, YOKOTHEN Activity & presentation to top management.
-Analyze the customer complaints and suitable corrective action.

SKILLS AND INTEREST AREA:

-Supplier evaluation and selection.
-Part evaluation, PPAP review and approval.
-Participating in benchmark review.
-Supporting supplier waste reduction and cost improvement process.
-Planning and control of Quality Assurance measures.
-Quality audits and implementation of inspection plan for incoming parts.
-To ensure that products meet the quality requirements.
-Quality Circle activities, internal auditing and Supplier auditing
-Concept development of CF and fool-proofing gauges.

PERSONAL PROFILE:

ADDRESS:12,Fox street,Stafford lane,TIP
DATE OF BIRTH:5TH May 19**
LANGUAGES KNOWN:English,Hindi and Tamil.

6. Quality assurance resume - Posted by Sonali Taste

NCW
91 982301****
NW_800@gmail.com

Career Objective:

To strive for continuous growth & development of the organization and aim to grow professional & personal skills by achieving the set organizational and personal goals.

Professional Profile: Total work experience: 8

-Presently working with ASS Ltd, as Manager-Quality since June 2009 reporting to Senior Director-External Manufacturing Quality.

-Worked with WTP Ltd EOU Facility as Executive-Quality Assurance from Nov 2007 to May 2009 reporting to General Manager Quality.

-Worked with RNXY Lab. Ltd as Officer-Quality Assurance from July 2006 to Oct. 2007 reporting to Manager Quality.

Quality and Compliance

-Identification, evaluation, auditing, qualifying the new third party contract manufacturing sites based on current and future business requirements on the basis of capabilities, risk assessment, facility audit, quality and safety systems, experience etc. through onsite audits.

-Conducting quality audits at various third party contract manufacturing sites. Designing, reviewing and tracking CAPA & monitoring the effectiveness of CAPA.

-Reviewing the quality agreements, adapting and maintaining them updated for all quality, compliance, regulatory, safety and pharmacovigilance aspects as per corporate requirement.
.
-Executing quality actions in the technology transfer of the products at the manufacturing sites. Monitoring product & system compliance during the product life cycle management.

-Ensuring GMP and regulatory compliance during the manufacturing, packaging, testing & distribution by conducting audits, documentation reviews and continuous follow ups.

-Extending quality support to local and regional supply chain, business development in identification, screening, auditing and qualifying new API and fill finish business partners.

-Extending support to global quality & compliance, regional supply chain, customer logistics, regulatory compliance, brand protection functions to meet high level enterprise objectives.

-Scanning the cross functional departments of the marketing company viz quality, regulatory, supply chain, R&D, medical for quality, regulatory and corporate compliance.

-Developing, upgrading the Quality Management Systems at the third party contract manufacturing sites to meet the current quality/regulatory and corporate requirements.

-To develop relationships with key business partners to ensure key business & quality goals are achieved. Designated Global process owner for API supplier qualification.

-Change control management: Evaluation, approval and scientific disposition of changes with impact assessment from quality and regulatory perspective.

-Management of Deviations/ Failure investigations: Assessment of impact of deviations and associated risk, their approval and closure for quality & regulatory compliance.

-Management of Good Distribution Practices: Quality management during and post distribution of the products in the market. Evaluation the cold chain temperature excursions & disposition.

-Auditing the company warehouses for quality, regulatory, safety & security requirements.

-Participate in the Environment, Health & Safety audits & ensure compliance to J&J standards.

-Escalation of critical product quality and regulatory issues, their investigation/ resolution to ensure compliance & business continuity.

-Complaint Vigilance Management: Handling, investigating, reviewing, closing and trending of customer complaints, responding to complainants, designing CAPA in Product Quality Management System (Software application for complaint handling).

-Inspections Management: Reporting of regulatory inspections in EDGE software application (Enterprise Data Gathering Engine). Acts as lead for internal J&J enterprise inspections.

-Conducting training programs on current technical/regulatory updates to internal J&J & third party supervisory staff to develop people.

-Responsible to release the J&J products in India market imported from internal J&J Sites.

Regulatory Compliance:

-Responding to FDA queries, show cause notices and other regulatory notifications.

-Preparing and applying the test and manufacturing license application with Health Authority.

-Reviewing the procedures, systems, documents to ensure the local regulatory compliance and to meet the global J&J regulatory standards.

-Liaise with government Labs viz CDL, CDTL and other health authority laboratories to ensure compliance and business continuity.

-To update the J&J product database available with the health authorities.

-Prepared for regulatory audits like USFDA, UK-MHRA and other regulatory authorities.

-Monitored and executed test batches for ANDA /regulatory filing and commercial batches.

-Reviewed manufacturing and quality related filing documentation.

-Conducted & monitored IPQA activities viz line clearance, calibrations, validations, sampling, in-process checks for tablets, capsules, dry syrups, sterile dry powder vials.

-Online review of batch records & related documentation for fast release of batches to market.
-Conducted air sampling & microbial swab sampling for area and equipments validation. Sampling of water samples (purified & water for injection) for chemical & microbial analysis

-Conducted the gap assessment of cross functional departments viz stores, manufacturing, packaging, engineering, quality control, human resource and their resolution as per applicable regulations during preparation of regulatory inspections.

-Conducted the annual physical evaluation of retain samples and interpreted observations with respect to product quality issues.

-Conducted calibration of IPQA laboratory instruments. Reviewed the calibration records for all plant instruments. Reviewed the unit operations of entire process to identify and exploit the cost reduction opportunities. Planning, organizing, implementing the cost reduction measures.

-Working on SAP system to maintain the ERP framework of the Quality Module.

Academic Qualification:

-Master of Business Administration in Operations Management from BNT University.

-Bachelor of Pharmacy (B. Pharm) from BNT University.

-HSC from State board.

-SSC from State board.

Extensive Exposures and Achievements:

-Honored for Business Integrity and Credo Compliance from ASS ltd.

-Honored by an appreciation letter from RNXY labs ltd to avoid a serious market complaint.

-Trained on Legal, Regulatory & Business policies viz FCPA, EHS standards, Information Asset Protection policies, Healthcare Compliance and Business Integrity and Soft skills.

-Successful experience of handling direct or indirect regulatory inspections viz USFDA, UKMHRA, MCC, WHO, ANVISA & consultants like Lachman & Van Zyl GMP international.

-Trained on Pre-Approval Inspections (PAI) for New Drug Application filing from India thru mock PAI’s in J&J.

-Drafted chapters for OPPI Guide on various quality assurance topics for Industry Guidance.

Interests:

-Reading.
-Playing chess.
-Writing poems.

Strengths:

-Leadership qualities.
-Negotiation skills.
-Honest.

Personal Details:

-Address:19,GTA street,HMA
-Date of Birth:21-06-19**
-Languages known:English,Hindi and Marathi.

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EXECUTIVE HIGHLIGHTS

- 12+ years of rich experience in Food Analysis and Quality Control / Quality Assurance, Microbiology Assurance, Food Safety Management ISO 22000:2005, Laboratory Management & accreditation ISO/IEC 17025:2005, Quality Management ISO 9001:2008, HACCP, GMP, GHP, HALAL Certification, Kaizen, 5S, SAP, QC/QA, Testing & Inspection, laboratory based research & quality assurance in Food, Beverages and R&D sector.

- Proven expertise in chemical & microbiological safety, Hygiene & GMP for safe food handling and warehouse sanitation. Demonstrated capabilities in designing and developing Food Safety systems/procedures, loss prevention activities and food safety-training programs customized to plant needs.

- Management Representative & Food Safety Team Leader to drive ISO 9001 & ISO 22000, Certified Internal Auditor of ISO 22000:2005 “Food Safety Management Systems/HACCP” ~ ISO/IEC 17025:2005 Laboratory Management Systems.

- Rich understanding of all aspects governing Quality Control and Inspection activities and up to date knowledge of latest technological advancements, regulations/guidelines and statutory compliances in the industry.

- Excellent communication and liaison skills and proven capability of effective management including inter and intra departmental coordination.

ACHIEVEMENTS

- Awarded for Food Safety Management System and HACCP as per ISO 22000: 2005 to the production facility at XXX.

- Awarded for Food Safety Management System and HACCP as per ISO 22000: 2005 to the production facility at XXX.

- Certificate for Quality Management System ISO 9001: 2000 and HACCP to the production facility at XXX

WORK EXPERIENCE
Dy. Manager-QC (Head-Quality Control / Quality Assurance) –since 20XX at XXXX

- Overall responsible for governing the Product Quality and Food Safety throughout the supply chain.
- Managing & facilitating the sampling, analysis and reporting of microbiological quality of raw materials, Packaging material swabs, Environment samples (water/air/hand swabs/equipments etc), Inprocess /Line samples, finished products.
- Documentation, Implementation & certification ISO 22000:2005 Food Safety Management System/HACCP, ISO 9001:2008 Quality Management Systems and ensuring the Quality norms for Infant Grade Dry Mix Sugar set by the Codex, BIS, FSSAI, IP and our prestigious customers as Nestle, Craftfood-Cadbury, Heinz, GSK, Coca-Cola, PepsiCo, Perfetti and other Food & Pharma customers.
- Overall supervision of Microbiology lab & implementation of Rapid microbiological test methods for product microbiology quality assurance and ensure all results are correct and accurate.
- Geared the activities for support & development of Suppliers and setting mutual objectives.
- Aligning QA function vision with the Company goals, leading the team for achieving the objectives and building alliance to support other functions and overall business
- Initiated turnaround efforts for ensuring that the food safety standards are followed in accordance with local and international requirements
- Conduced hazard analysis based both on food safety as well as general safety in order to provide safe working environment
- Developed all specifications for purchased ingredients and food packaging materials, as well as procedures for incoming inspection to ensure compliance
- Successfully conducted regular audits and food safety awareness trainings for vendors
- Imparted training to employees on the various issues related to food safety, maintenance and implementation of HACCP standards
- Conceptualized and implemented measures for enhancing operational efficiency & optimizing resource optimization
- Constantly monitored day-to-day operations at micro level, maintained daily checklists and executed the tasks assigned in accordance with organizational standards
- Conduct foreign body audits of ISO 22000, ISO 9001, Halal, SEDEX and customers
- Training of personnel regarding FSMS ISO 22000/HACCP, GMP, GHP, GLP, 5S, Kaizen


ABC Ltd. JUN XX – JUN XX
Assistant Manager-Quality (Hygienist)

- Documentation, Implementation and drive ISO 22000:2005 “Food Safety Management System” and ensuring the Quality norms for Infant Grade Dry Mix Refined Sugar set by the Codex, BIS, PFA, IP and our prestigious customers as Nestle, Dabur, GSK, Wrigley and other Food & Pharma customers etc.
- Managing & facilitating the sampling, analysis and reporting of microbiological quality of raw materials, Packaging material swabs, Environment samples (water/air/hand swabs/equipments etc), Inprocess /Line samples, finished products.
- Implementation of Rapid microbiological test methods for product microbiology quality assurance and ensure all results are correct and accurate.
- Microbial Risk Assessment and Qualification of Consumer Product (HACCP study-products and industrial services).
- Managing laboratory and ensuring adherence to ISO/IEC 17025:2005, handling /maintenance and calibration/validation of lab instruments/equipments.
- Ensure the high degree of hygienic environment in process to packing areas.
- Troubleshooting on pathogen or microbiological out of norms in the production (investigative sampling- line and environment samples).
- Monitoring, sanitation and validation of the process equipments as well as laboratory equipments, Validations activities in the lab.
- Handling customer complaints by analyzing and proposing corrective & preventive actions.
- Conduct foreign body audits of ISO 22000: 2005, Halal, Sedex and customers.
- Training of personnel regarding FSMS ISO 22000/HACCP, GMP, GHP, GLP, 5S, Kaizen etc.
- Weekly full audit of GMP violations in factory and follow up on the gaps identified (1week per plant). 5S implementation in the factory.
- Generate pathogen-monitoring results daily. Compile monthly summary for review by management. Corrective Action Reports for all food safety related deviations. Pest Control Monitoring Report.

XYZ MAR XX-JUN XX
Assistant Manager (QC/QA)

- Drive the QC lab as per GLP.
- Sampling, analysis and reporting of microbiological quality of Packaging materials, Environment samples (air/hand swabs/equipments etc), Inprocess /Line samples, finished products.
- Ensuring adherence to IS 13428:2005, ISO 9001:2000 and HACCP norms.
- Consistent evaluation of vendor performance to ensure supply of quality material.
- Preparing documentation as per IS 9001:2000 and HACCP.
- Responsible for chemical and microbiological testing of natural mineral water to ensure that they are "fool-proof" and specific to IS 13428:2005.
- Inspecting & maintaining quality standards for incoming packing & raw materials, ensuring stringent adherence to quality standards, norms & practices, identifying gaps and taking corrective action.
- Ensuring delivery of tested, safe and quality product.


ACADEMIC QUALIFICATIONS

- M.Sc. (MICROBIOLOGY); XYZ University, Bilaspur (CG)


PROJECTS/TRAININGS

- 3 days workshop on “GFSI Capability Development” (FSSC 22000) at The Westin, Gurgaon.
- PAS 220 Pre-requisite Programmes for FSSC 22000:2011 Food Safety System Certificate from SGS.
- ISO 22000:2005 Food Safety Management Systems -Internal Auditor Course from Det Norske Veritas (DNV), New Delhi
- Estimation of Uncertainty in Measurement in testing by Mr. B. Singh, Dy. Director, Govt. of India, Indian Institute of Quality Management (IIQM), Jaipur in association with Centre for Analysis, Research and Training (CART), New Delhi
- Food Analysis & Quality Control from Central Food Technological & Research Institute (CFTRI), Mysore
- Laboratory Quality Management System and Internal Audit as per ISO/IEC 17025: 2005 from Govt. of India, Indian Institute of Quality Management (IIQM), Jaipur
- Fragrances and Flavour, Formulation and its Application from Govt. of India, Fragrances and Flavour Development Centre (FFDC), Kannauj
- Chemical and Microbiological Analysis of Food and Food Products from Food Research and Analysis Centre (FRAC), New Delhi

Participations
- In preparation of Proposal to setup Food Testing and R&D Labs in U.P. and Uttarakhand under Ministry of Food Processing Industries (MOFPI), Govt. of India
- Conducted three days EDPs on Food Processing awarded by DSIR, Govt. of India in Oct. 2006 and Sept 2005
- In technology transfer of soft drink concentrates at Deptt. of P. P. S. F. T., Central Food Technological Research Institute, Govt. of India, Mysore
________________________________________

Personal Details

Date Of Birth:
Languages Known:
Address:


Quality assurance resume sample 12-22-2012 12:22 AM

Quality Assurance Resume

Nikhil XXXXXXX
Mobile No: 9xxxxxxxxx
Email Id : nikxxxxxx@yahoo.co.in


OBJECTIVE:
-A top performing quality assurance manager with a 9 year record of achievement in the IT and Engineering sectors.
-My natural business acumen and relationship building skills have allowed me to achieve career growth and a special talent for transitioning strategy into action and achievement.
-Looking to utilize my background in quality assurance management with a respected organization that rewards hard work and innovation.


COMPUTER KNOWLEDGE: MS Office ( MS Word, Excel, Power Point ).


EDUCATIONAL DETAILS:
-M.Sc.( MICROBIOLOGY) form XXXXXXX University
-B.Sc. (MICROBIOLOGY) form XXXXXXX University


EXPERIENCE DETAILS:-
Company : XXXXXXXX SINCE APRIL XXXXX

designation : SR. MANAGER - QUALITY ASSURANCE

Responsibilities:
-Handling of 4 different Plants Quality Assurance Activities likely Inject able ( Regulatory ) , Infusion - 2 , Infusion - 4 and API ( CL-3 ).
-Leading a team of 28 professionals engaged in the field of QA ( Document control, IPQA, Validation, Qualification and Training activities ).
-To prepare and implement Quality Assurance Procedures (QAP) .
-To review and approve SOPs of various functional sections.
-To review and approve RMS/PMS/SPS/FPS.
-To review and approve quality system documents like, Change control proposals, Deviations, Incident reports , OOS and CAPA reports.
-To investigate market complaints and it's recordation.
-To resolve non-conformance issues and initiate remedial action plan.
-To conduct building maintenance audit of shop floor.
-To monitor shop floor activities in line with SOPs.
-To plan and organize annual training plan with Training coordinator on cGMP and technical aspects.
-To coordinate with Corporate-QA professionals for international regulatory inspection.
-To coordinate with Regulatory department for various documentation job.
-To assist Unit Head for the preparation of regulatory inspections and compliance report.
-To allocate job responsibilities to the QA professionals.


Company : XXXXXXXX SINCE AUGUST XXXX TO 04 APRIL XXXX
Designation : MANAGER - QUALITY ASSURANCE

Responsibilities:
-Handling And Management For Quality Assurance for Oral Facility ( Tablet , Capsule , Liquid )
-Handling of Management of Quality Assurance activities of Injectable ( LVP ).
-Implementation and Development of QA system
-Handling of Training - On Job And cGMP
-Handling and participate in Internal Audits and External Audits.
-Handling of Deviations / Change Control / OOS / Failure Investigations
-Handling and releasing of Finished Products
-Handling of Market complaint and its compliance
-Participation for the Product process improvement and for new products development
-Handling and development of Art Works and its final Approvals
-Handling of Annual Products Review of Products
-Handling of Documentation and Validation Activities
-Participation in the Inject able plant project and its Qualification ( IQ / OQ / PQ )


Company : - XXXXXX SINCE JUNE XXXXX TO AUGUST XXXX
Designation : SR. EXECUTIVE - QUALITY ASSURANCE.

Responsibilities:
-Handling And Management For Quality Assurance & Microbiological Activities Of QA/QC, Includes Validation.
-Support To Manufacturing Departments [ Tablets,Oral Liquid,Injectable And Bulk Drug (API) ] of USFDA , MHRA , MCC , IVAX , CANADA , ZENTIVA , LATVIA , ETC APPROVED FACILITY.
-QUALITY ASSURANCE AUDIT for the Formulations (Tablets/Oral Liquid/Injection/ Packaging Material Store / Raw Material Store) And Bulk Drug (API).
-Implementation of All Microbiological Activities And Its Documentation System.
-Handling And Management of Water System
-Successfully Independently Handling of USFDA Inspection was held in Nov-2005.
-Handling of Quality Assurance Documentation, Internal Audits of Oral Solid Dosage Forms And Inject able Facility.


Company : XXXXXXX SINCE JULY XXXX TO FEBRUARY XXXXX
Designation : OFFICER - QUALITY ASSURANCE.

Responsibilities:
-Projection Of QA/QC, IQ/OQ/PQ OF QA/QC Instruments / Equipments And Its Calibration, And Validation Schedule Preparation.
-Preparation Of SOP'S / Calibration / Process Validation / Validation Documentation.
-Training To Operators / Supervisors / Executives about cGMP AND cGLP.
-Quality Assurance Activity Of Tablet / Injection / Packing Department Of MHRA , TGA , MCC , UGANDA, TANZANIA, LOCAL FDA AND SMITH KLEIN BEECHEM.


ACHIEVEMENTS:
-Faced UK-MHRA , USFDA , MCC , TGA , ANVISA ( BRAZIL ) , GERMANY AUDIT , And Many Other REGULATORY INSPECTIONS , LOCAL FDA And Other REPUTED External Customers Inspections.
-ACTIVE PARTICIPATION IN REGULATORY INSPECTIONS And Other INTERNATIONAL INSPECTIONS.
-Developed Self Skills To Achieve Quality, Productivity And Management.
-Established Pyrogen And Toxicity Testing Laboratory, Microbiology Laboratory.
-Established Quality Assurance ( IPQA ) System.
-Established New Water System.
-FDA APPROVED in PHYICO-CHEMICAL TESTING AND IN MICROBIOLOGICAL TESTING AND STERILITY TESTING.


RESPONSIBILITIES AND ACCOUNTABILITIES:
-Planning The Activities And Laboratory Management.
-Training To Operators / Supervisors / Officers / Microbiologists As Per cGMP AND cGLP.
-Documentation As Per Regulatory Requirement.
-Handling Of OOS And Other Failure Investigations.
-Support To Validation Activities For Sterile And Non-Sterile Area Activity.
-Review And Preparation Of SOP'S / STP'S / GTP'S / VALIDATION


PROTOCOLS.
-Review In process operations and its documentation.
-Conduct Internal Quality Assurance Audits & Its Program.
-Review Of Monthly Trends.
-Product Approval And Release.
-IQ/OQ/PQ Of New Laboratory Instruments.
-Planning And Calibration Of Laboratory Instruments.
-Method Developments , Validation , Cleaning Validation For Microbiological Tests And Hygienic


Quality Point Of View.
-Purchase Any Laboratory Requirements As Per Provided Budget.
-Annual Laboratory Requirements Budget Preparation.


ANALYTICAL SKILLS:
-Assurance Of Line Clearance For Manufacturing And Packing.
-Assurance Of A Through Manufacturing Process And Final Packing Of Drug.
-Assurance Of Equipment Cleaning.
-Assurance Of Drug Or Product As Per Its Master Formula .
-Assurance Of Any Physical Tests Of Drug Or Product
-Sterility Testing As Per USP , BP , EP , and as per TGA Guideline.
-Microbial Limit Testing Of Raw Materials And Finished Products As Per USP, BP , EP , IP.
-Bacterial Endotoxin Testing By Gel Clot Method , Quantitative Analysis Method And Pyrogen Testing Method.
-Microbiological Assay Of Vitamins And Antibiotics.
-IN PROCESS - QA Of Sterile And Non-sterile Formulations
-Water Analysis And its Validations.
-Culture Handling And Identification Of Microorganisms By BIOLOG Kit And Other Methods.
-Environmental Monitoring Program Of Sterile Area by [ Settle Plate, Air Sampling ,Surface Monitoring ,Personnel Hygiene , Non-Viable Particle Counts ( ABPC ) ].
-Bioburden Testing Of WFI , Purified Water and Inject able Bulk Products.
-Particulate Matter Testing In Inject able Products By Light Obscuration Method ( HIACO - ROYCO ).
-Total Organic Carbon ( TOC ) Analysis Of Water.
-Sanitization Agents / Disinfectants Qualifications.
-Preservative Efficacy Test Qualifications.
-Establishment Of Analytical Procedures and its compliance.


PERSONAL DETAILS:
-Date of Birth:
-Language:
-Address:


Swati Das 11-27-2012 06:20 AM

Quality Assurance Sample Resume

Saahil Goradia
Tel: +91999*********
Email ID - *********@gmail.com

Career Summary:

-4 year’s work experience as a quality assurance engineer.
-Proven ability in forming and directing effective QA programs.
-Effective in working in a cross cultural environment.

Areas of Expertise:

-Communication skills
-Product development
-Product testing
-Operating System
-Presentation Skills
-Team Leader
-Motivator

Professional Experience:

Company A – from 2010 to present

Company B – from 2008 – 2010

Responsibilities:

-Responsible to develop and implement quality assurance plans
-Responsible for functional test planning and co-ordination
-Monitor testing progress
-Work with test co-ordinators to ensure tests are implemented accurately for the improvement of the product
-Promote co-ordination of quality assurance activities
-Responsible for strategic planning and program development

Achievements:

-Acted as a lead Quality Assurer for one of the departments
-Successfully trained 2 people for the role of Quality Assurance
-Flawless Quality Assurance program was planned and implemented

Educational Qualification:

-Masters in Engineering and Technology
-Bachelors in Engineering and Technology

Extra - Curricular Activities:

-Reading
-Surfing net
-Travelling
-Badminton

Personal Details:

Date of Birth – 6th June
Languages known – English, Hindi, Spanish
Address - Mumbai


Nupur Bhargava 11-27-2012 02:54 AM

 

 

 
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