Job Summary:
- Compile annual product quality reviews (APQRs) per applicable SOPs.
- Collect, analyze, and summarize product review data correctly and completely in a timely manner.
Job Responsibilities:
- Perform Annual Product Quality Reviews (APQRs) compilation as per SOP, including:
- Manufacturing Process Overview
- Batches Released / Rejected
- APIs, Excipients
- Changes
- Test Method and Specification
- Manufacturing / Process Validation, Equipment, and Utilities Qualification
- Sterility Validation / Qualification (if applicable)
- Packaging Component Deviations/Changes
- Compendial Review
- Deviations
- Critical In-Process Attributes
- Analytical Test Results
- Recalls and Field Alerts, Returns
- Retention Samples Review
- Technical Agreements (as appropriate)
- Marketing Authorizations Variations and Post Market Commitments (as appropriate)
- Complaints
- Stability
- Conclusion and Product Rating
- Concerns, Recommendations, and Issues for Follow-Up
- Perform complete and correct transactions of the data as per SOP/WIs.
- Summarize and trend analytical data from LIMS or other acceptable systems.
- Ensure that the complete APQR is submitted for review and accepted by the Reviewer and Project Leader QA Product Review/Manager, QA Product Review.
- Coordinate with Project Leader(s) – QA Product Review / Manager for completion of the projects.
- Compile the APQRs within required timelines to ensure that there is adequate time for approvals.
- Respond to Project Leader’s queries for APQR summary reports as required.
- Assist in preparation, review, and revision of Standard Operating Procedures (SOPs) as required.
- Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements, and established safety standards.
- Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.
