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Work as a Sr. QA / QC Executive @ USV Limited - 2 Openings

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USV is aleading healthcare company with the following areas of focus: Generics, Active Pharmaceutical Ingredients (APIs) and Biosimilars. 68% of our business is contributed by India Operations and the rest by export of APIs and Generics.
USV is a 48 year old healthcare company which began as a joint venture with USV&P Inc, a subsidiary of Revlon. Product range consists of Generics, Active Pharmaceutical Ingredients and Biotherapeutics that are manufactured in our modern cGMP compliant plants located in India.

Post: QA/QC Executive

Job Description:
- To review the QC / Manufacturing reports and guide QC and manufacturing function for GMP compliance.
- Calibrations and validations data and document review .
- Handle Internal Audits, CAPA, Change control , OOS  and deviations management, OOT, investigations related to process and product failures, market complaints etc.
- Equipment qualifications, Failure investigations and OOS investigations
- Equipment maintenance monitoring and review HAVAC system monitoring and review.
- Utility and process validations.
- Batch monitoring and in process clearance for Biosimilar API manufacturing.
- Handle technology transfers and analytical method transfers from R&D to plant for biosimilar products.
- Review of technology transfer documents
- Knowledge of regulatory pathways for product registrations in semi-regulated and regulated markets for Biosimilars.
- Stability study protocols and schedules preparation & review of stability data.

Candidate Profile:
Candidate must have experience in Quality Assurance of Biotechnology Processes
Must have experience of regulatory audits by agencies like US-FDA / EMEA / ANVISA / MHRA etc.
Must have experience in qualifications, process  validations of recombinant proteins
Must be familiar with product characterization analysis as per EMEA and ICH guidelines.
Must be familiar with process characterization and establishing the design spaces. Familiar with facility design concepts and commissioning and qualifications for biotechnology products.
Candidate must have experience in Biotech / Serum / Vaccine companies.

Additional Information:
Experience: 4-8 years
Location: Mumbai
Education: B.Sc, M.Sc, B.Tech-Biochemistry, M.Tech-Biochemistry
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: QA/QC Executive
End Date: 25th May, 2011

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