Quality Control Assurance

OBJECTIVE:

To utilize my skills as a QA Associate / QA Auditor / Documentation

Specialist / Technical Writer position

Highlights of qualification:

. Over 10 years of experience working in pharmaceuticals and chemical

industries

. Familiar with FDA and ICH guidelines, USP, BP, EP pharmacopeias

. Coordinated with R&D, Manufacturing, Quality Control, Quality Assurance

and Planning departments

. Assure documentation is accurate and in compliance

. Excellent knowledge of GMP, cGMP, GLP, MSDS and SOP's

. Good knowledge of change control process, NCR, OOS, deviations and

IOPQ's

. Good interpersonal, organizational, multitasking abilities,

troubleshooting and analytical skills

. Detail oriented, very flexible, responsible and able to work in a team

. Efficient user of Microsoft Office (Word, Excel, PowerPoint)

. Excellent user of Documentum, SAP and knowledge of LIMS

. Prepare, issue, review, distribute and maintain master controlled

documents such as Standard Operating procedures (SOP's) and batch

records. Issue/Reissue Certificate of Analysis

. Hard worker, fast learner, willing and able to assume responsibility

and can work independently

. Worked as member of Plant Safety Committee, ECM team and Social

Committee at Apotex

Work History:

(1) Cardinal Health, East Rutherford, NJ, USA

Quality Control / Quality Assurance Specialist:

May 2012 - Continue

. Perform review of the manufacturing batch records for completeness and

final release

. Make sure procedures are followed as per cGMP and regulatory

requirements

. Perform and/or assists with internal and external quality assurance

audits

. Participate in review and approval for investigations associated

with Deviations, Corrective and Preventive Actions (CAPA),

Environmental Discrepancy Reports and Alert Level Reports

. Approves or rejects components, containers, closures, in-process

materials, packaging materials, labeling and products to ensure

compliance with procedures and specifications

. Advises the Site Supervisor and QA manager of concerns that could

impact the quality of the product

. Make sure Calibrations and maintenance schedule are maintained for

equipments

. Initiate and work on change controls for approval

. Train/retrain staff for new/revised procedures, participate in QA/QC

call for updates

(2) Henkel Inc., Rocky Hill, CT, USA

Regulatory Affairs Specialist: (Contract) October

2011 - April 2012

. Prepare product Material Safety Data Sheets (MSDS) and label

warning statements in SAP

. Create hazard warning labels regarding hazards of ingredients in

products

. Prepare MSDS summary sheets, Letter of Compliance and Derogation

letter for customers

. Correspondence with customers for queries

(3) Apotex Pharmachem Inc., Brantford, ON, Canada

Documentation Chemist: June 2008 -

January 2011

. Creation of SOP's, Test methods, Reports, issue/reissue C of A's as per

current shelf life

. Assessed change controls and prepared submissions arising from the

change control process

. Reviewed documents including SOP's, analytical procedures and revision

of SOP's as per review schedule, prepare monthly reports and archived

analytical data and information

. Proper scanning, filing, distribution and circulation of documents

. Responsible for documentation and logbooks record keeping as per GMP

and SOP's

Chemical Operator: Aug., 2006 -

May 2008

. Manufactured products according to established procedures and GMP

guidelines

. Responsible for batch record and log books record keeping as per GMP

and SOP's

. Coordinated with quality control and facility department for achieving

production target

. Performed cleaning and sanitation of reactors, hoppers, pumps and hoses

during production

(4) Body Blue Inc., Mississauga, ON, Canada

Compounder & Chemical Preweigher: Nov. 2005 -

July, 2006

. Manufactured body care products according to established

procedures and GMP guidelines

. Responsible for documentation and logbooks record keeping as per

GMP and SOP's

. Coordinated with quality control, packaging and facility

department for achieving production target

(5) I.P.C.L., Vadodara, Gujarat, India

Chemical Laboratory Technician: 1989 -

2004

. Preparation and standardization of solutions and calibration of

instruments as per SOP

. Responsible for analysis of raw materials, intermediates and

finished products according to SOP

. Result entry and reports generation work using LIMS

. Results reporting using LIMS, maintain chemical inventory

supplies for laboratory

. Responsible for documentation and log book record keeping

. Worked in Research center and plant Quality Control laboratory

. Worked on GC, HPLC, TLC, UV-VIS, IR, Karl Fischer Moisture

Analyzer, pH-meter, Viscosity meter

. Performed analysis of water samples for various tests (e.g.

Hardness, pH, TDS)

Education:

Industrial Pharmaceutical Technology program: June 2005 -

July 2006

. Laboratory Assay Methods (Potency, Weight variation, Hardness,

Dissolution, ID & Limit Tests)

. Industrial pharmaceutical manufacturing methods and product

formulation

. HPLC and GC (Instrumentation, Calibration and analysis)

. Industrial Drug Legislation

Seneca College of Applied Arts & Technology @ York University, TORONTO

M.Sc. (Master of Science) Organic Chemistry

April 1989

S. G. University Surat, Gujarat, India

References: Available upon request

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