Analytical ,Quality Control and Regulatory affairs

CURRICULUM VITAE

Mrs. Avinash V Mehra

Contact Details : Ambernath CHS,

Plot no: 19.

Katrap,

Badlapur (E) 421503

Mobile: 988*******

Email: avivikas @yahoo.com

Date of Birth : Dec 09, 1972

Educational Summary:

Post graduate diploma in Drug Regulatory affairs

M.Sc (Chemistry) from Mumbai University

B.Sc(Chemistry) from Mumbai University

Achievements and Prizes:

• Shri Jayaram Mani Prize Award (1993) for securing highest marks in B.Sc.

• S.I.E.S College Prize (1993) for securing highest marks in B.Sc.

Careers Summary:

Organization : ALA Chemicals Pvt. Ltd

Designation : Quality Manager

Duration : April 2009 to till date

Work Nature : Provide quality product to customer

Quality Control and Assurance

Job Profile

• Evaluation of raw materials, in process, finished products and there performance.

• Investigation of market samples and complaints, new vendor sample approvals and development of new products.

• Validation of analytical test methods as per ICH guidelines.

• Analysis of stability study samples.

• Verification and Validation (IQ, OQ, PQ) for instruments.

• Calibration of Instruments like GC, HPLC, AAS, FTIR and UV visible spectrophotometer.

• Development and Standardization of analytical methods as per pharmacopoeia and Regulatory guidelines or customer specific requirements.

• Application and Method development in Chromatography techniques.

• Technical assistance to production and quality assurance during manufacturing.

• Management representative for ISO 9001:2008 from BVQI.

• Coordination and communication with multi disciplinary team.

• Supervision of team and skill development of analysts.

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Organization : MSN Pharma Chem Pvt Ltd

Designation : Analytical Executive

Duration : Jan 2008 to April 2009

Work Nature : Analytical Development lab

Job Profile

• Validation of analytical method as per ICH guideline.

• To validate the analytical method for assay, related substances by HPLC and

dissolution of drug product

• Validation protocol and report preparation for ANDA projects.

• Assay, CU and related substances method development of drug product by HPLC.

• DMF files review and verification.

• To determine the stability and forced degradation study of drug product and drug substance and relevant report preparation.

• Routine analysis of finished product .Analytical method verification as per DMF.

• Preparation of product STP, Instrument SOP, validation protocol and report review of routine analysis report and validation report

• Review Daily Instrument Logbook and analysts lab note book. Work Distribution among the Group.

• Carried out technology transfer of various products from R & D to QC Lab and documentation of the same.

• Audit preparation-US and Europe Market

Organization : Baerlocher India R & D Pvt. Ltd. (MNC)

Designation : Analytical Research Officer

Duration : Sept 1998 to Dec 2007

Work Nature : Development of convenient, reproducible and economical analytical methods and to ensure Customer Satisfaction by providing reliable test reports.

Job Profile : Analytical Development lab

• Operating modern analytical instruments:

Headspace GC, AAS, UV, FTIR, HPLC (Reversed phase), HPTLC, GPC,

TGA, DSC.

• Proficient in Application, Maintenance and Theory of Chromatographs.

• Experience using Chemserver, Chemstation and total chrom software.

• Analysis of competitor samples and developing tailor made products.

• Analysis of raw materials, intermediates and final products.

• Completed training course from Technical Center of PERKIN ELMER

Gas Chromatography Mass Spectroscopy,

FTIR

Atomic Absorption Spectrometry

• Acquired ISO 9001:2000 Certification(practice GLP)

• Done training at Italy (Lodi) in development and validation of analytical methods and instruments.

• Performing IQ/OQ/PQ for all instruments.

• Solving basic problems with instrumentation or methods.

Organization : Indian Institute of Technology, CESE, Powai.

Designation : Junior Research Assistant

Duration : June 1996 to Aug 1998

Work Nature : Handling and Maintenance of all analytical instruments and providing analytical support

Job Profile :

• Conducted laboratory sessions for M.Tech. Students.

• Carried out analysis on various sophisticated analytical instruments like AAS, HPLC, Ion Chromatography, Gas Chromatography, UV-Visible spectrophotometer, Voltammeter, Total Organic Carbon analyzer.

• Worked for project on Study of effluents from MIDC of Chiplun, Thane, Roha Industrial Estate, Lote Parshuram, Taloja Industrial Estate, Patalganga Industrial area.

• Worked for consultancy project on "Environmental Management Plan- for JNPT".

• Projects worked on.

"Environmental Status of Trans Thane Creek Area" sponsored by MPCB, awarded to MITCON, PUNE, and sub contract to IIT.

“EIA of Combined Hazardous Waste Disposal Facility"

• Done consultancy work for organizations like KOL- International Corporation, Space Engineers & Constructor, NOCIL, TFIL, STANDARD ALKALI, and BAYER

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