QC Manager

Key Responsibilities

1. 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.

2. 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.

3. 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.

4. 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+).

5. 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: ₹60,000.00 - ₹90,000.00 per month

Work Location: In person