1. 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.

2. 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.

3. 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.

4. Leadership & Resource Management

- Manage manpower planning, shift rosters, and team utilization.
- Train QC personnel on current Good 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

Benefits:

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

Work Location: In person

📌 QC Manager (India)
🏢 Bills Biotech
📍 India