Job Purpose
- To coordinate, prepare, review, and maintain the Annual Product Review (APR) or Product Quality Review (PQR) for pharmaceutical products in compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company quality management systems.
- The role ensures continuous monitoring of product quality, process consistency, and identification of opportunities for continual improvement.
Key Responsibilities
Annual Product Review Activities
- Develop and maintain the Annual Product Review schedule.
- Collect, compile, and analyze manufacturing and quality data for all products.
- Prepare Annual Product Review (APR) or Product Quality Review (PQR) reports within established timelines. .
Data Collection and Analysis
- Review and trend:
- Batch manufacturing records.
- Batch packaging records.
- Process validation status.
- Analytical testing results.
- Product quality trends.
- Critical Process Parameters (CPPs).
- Stability study results.
- Out-of-Specification (OOS) results.
- Out-of-Trend (OOT) results.
- Deviations.
- Change controls.
- Corrective and Preventive Actions (CAPAs).
- Customer complaints.
- Product recalls (if applicable).
- Returned products.
- Environmental monitoring results
- Equipment qualification and maintenance data.
- Training in 1SO 22000 auditing will be an added advantage
Compliance Responsibilities
- Assist during regulatory audits by providing APR/PQR documentation.