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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

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

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