QC Manager

API Pharmaceutical Testing Quality Control

1. Laboratory Management

• Manage day-to-day QC laboratory operations including chemical and instrumental analysis.
• Ensure proper functioning of analytical instruments such as HPLC, GC, UV, IR, KF, etc.
• Maintain laboratory safety and housekeeping standards.

2. Testing & Analysis

• Review and approve specifications, test methods, and analytical reports.
• Ensure testing of raw materials, intermediates, finished products, and stability samples as per approved procedures.
• Monitor out-of-specification (OOS), out-of-trend (OOT), and deviations.

3. Compliance & Regulatory

• Ensure compliance with cGMP, GLP, and regulatory guidelines (USFDA, MHRA, EU GMP, WHO).
• Handle regulatory inspections and audits.
• Prepare and review SOPs, protocols, and reports.

4. Documentation & Data Integrity

• Ensure ALCOA+ principles are followed for data integrity.
• Review and approve analytical data and documentation.
• Maintain audit-ready documentation at all times.

5. Stability Studies

• Oversee stability program as per ICH guidelines.
• Review stability data and ensure timely reporting.

6. Team Management

• Lead, train, and develop QC team members.
• Allocate work and ensure productivity and efficiency.
• Conduct performance evaluations.

7. Calibration & Qualification

• Ensure calibration and maintenance of instruments.
• Oversee method validation, verification, and transfer activities.

8. Investigations & CAPA

• Lead investigations for OOS, deviations, and customer complaints.
• Implement corrective and preventive actions (CAPA).