QC Manager
4 days ago
Key Responsibilities
Laboratory Operations
Manage QC laboratory activities for raw materials, intermediates, finished products, and stability samples.
- Review and approve analytical reports, COAs, and test data.
- Ensure calibration and maintenance of instruments like HPLC, GC, UV, FTIR, Dissolution Apparatus, etc.
Implement proper documentation as per 21 CFR Part 11, WHO-GMP, and GLP norms.
Compliance & Quality Systems
Ensure compliance with DCGI, State FDA, WHO, and export regulatory requirements.
- Review and maintain SOPs, STPs, and Specifications for all materials and products.
- Handle OOS, OOT, deviations, and CAPA investigations.
Support internal and external audits and regulatory inspections.
Team Leadership
Supervise and train QC analysts, chemists, and microbiologists.
- Allocate daily testing work and monitor laboratory productivity.
Conduct competency evaluation and skill enhancement sessions.
Documentation & Reporting
Approve analytical results and maintain batch-wise QC release records.
- Manage retention samples, stability studies, and trending reports.
Oversee documentation control as per data integrity principles (ALCOA+).
Cross-Functional Coordination
Coordinate with QA for batch release and market complaints.
- Collaborate with Production for in-process controls and process validations.
- Work with Procurement for vendor qualification of raw materials and packaging materials.
Qualifications:
- Education: M.Pharm / B.Pharm / M.Sc (Chemistry / Microbiology)
- Experience: Minimum 8–12 years in QC (pharmaceutical formulations), with at least 3 years in a managerial/supervisory role.
Knowledge Required:
- HPLC, GC, UV, dissolution, and other analytical techniques
- WHO-GMP, ICH, and GLP guidelines
- Stability studies, LIMS, and data integrity
Job Types: Full-time, Permanent
Pay: ₹60, ₹90,000.00 per month
Work Location: In person
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