USV Private Limited is a prominent Indian multinational pharmaceutical and biotechnology company founded in 1961, specializing in diabetes and cardiovascular therapeutics. Headquartered in Mumbai, it is a market leader in Oral Anti-Diabetic (OAD) drugs and offers a diverse portfolio, including APIs, biosimilars, and injectables, alongside consumer healthcare products like Sebamed.
Post : Assistant Manager - QA (IPQA) Sterile / Injectables
Experience : 9–12 Years
Qualification : B. Pharm / M. Pharm / M. Sc
Dept. : Sterile QA
Section : IPQA
Location : Daman
Job Description
1. Documentation & Document Control: Manage the complete lifecycle (preparation, issuance, retrieval, and destruction) of all QA documents, including SOPs, Logbooks, BMRs, and BPRs, while maintaining the documentation cell.
2. In-Process Quality Assurance (IPQA): Conduct line clearances, perform in-process checks, and execute Acceptable Quality Level (AQL) inspections across general manufacturing, packing, and aseptic areas.
3. Aseptic Area Oversight & Media Fills: Provide strict QA oversight during aseptic processing, manage aseptic process simulations (media fills), and prepare related protocols, trend reviews, and personnel tracking matrices.
4. Sampling & Dispensing Verification: Oversee sample collection for commercial submission and validation batches, and rigorously verify the dispensing of raw and packaging materials.
5. Shop-Floor Compliance & Environmental Monitoring: Ensure strict cGMP compliance through frequent shop-floor rounds, monitor environmental controls/cleanliness, and verify routine equipment printouts (CIP/SIP, Autoclaves, incubators).
6. Validation & Qualification Execution: Actively participate in the preparation and execution of Process Performance Qualifications, Cleaning Validation protocols, Hold Time studies, and Master Formula Records (MFR).
7. Product Reviews & Audit Trails: Prepare Annual Product Quality Reviews (APQR), inspect finished product consignments, manage control samples, and review equipment audit trails for both aseptic and non-aseptic areas.
USFDA-approved plant experience is compulsory
• Strong exposure to Sterile / Injectable manufacturing
• Sound knowledge of cGMP, IPQA & aseptic operations
• Strong focus on quality & patient safety
Interested candidates can share their CV at: sanafatma.khan@usv.in
Subject Line : Assistant Manager – QA (IPQA) Sterile/Injectables – Your Name
Last Date : 31st August 2026
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