USV Limited B.S.D Marg, Govandi,
MUMBAI, Maharashtra
Sr.Executive - Quality Assurance (Biotech Plant)
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.
Desired 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.
Must be ready for relocation.
Experience 4 - 8 Years
Education UG - B.Sc,B.Tech/B.E. - Bio-Chemistry/Bio-Technology
PG - M.Sc,M.Tech - Bio-Chemistry/Bio-Technology
Compensation: Compensation will be at par with the industry standards
Location Navi Mumbai
Contact USV Limited
B.S.D Marg, Govandi,
MUMBAI,Maharashtra,India 400088
Email hrd@usv.co.in
Website http://www.usvindia.com
B.S.D Marg, Govandi,
MUMBAI,Maharashtra,India 400088
Email hrd@usv.co.in
Website http://www.usvindia.com
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