Laboratory Operations & Testing
Oversee routine and advanced analytical testing of raw materials, packaging materials, water systems, intermediates, and finished APIs.
Manage qualification, calibration, preventive maintenance, and troubleshooting of high-end analytical instruments (HPLC, GC, UV-Vis, FTIR, LC-MS/GC-MS).
Monitor lab inventory, consumable supplies, and reference standard management.
Compliance & Data Integrity
Implement and maintain ALCOA+ principles and strict data integrity measures across the laboratory.
Ensure 21 CFR Part 11 compliance for computerized systems, software control, and user access management.
Face and support regulatory audits (USFDA, EDQM, PMDA) and customer audits.
QMS & Problem Resolution
Lead investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, and laboratory incidents.
Drive effective Corrective and Preventive Actions (CAPA) and ensure timely closures.
Review and approve Certificate of Analysis (COA), Standard Testing Procedures (STP), protocols,



and analytical reports.
Leadership & Resource Management
Manage manpower planning, shift rosters, and team utilization.
Train QC personnel on current Positive Laboratory Practices (cGLP), cGMP, data integrity, and safety protocols.
Coordinate smoothly with cross-functional teams including Production, Quality Assurance (QA), Regulatory Affairs, and R&D.;
Qualification: M.Sc. in Chemistry (Organic/Analytical) or B.Pharm / M.Pharm.
Experience: 10 to 15+ years of relevant experience in QC within an API or bulk drug manufacturing setup. Regulatory market exposure (USFDA/EU) is mandatory.

Job Type: Full time

Pay: ₹1,000,000.00 - ₹1,200,000.00 per year

Advantages:
Commuter assistance
Food provided
Health insurance
Internet reimbursement
Leave encashment
Provident Fund

Work Location: In person

📌 Qc Manager Manjusar
🏢 Bills Biotech
📍 Manjusar