- Compile annual product quality reviews (APQRs) per applicable SOPs.
- Collect, analyse and summarize product review data correctly and completely in timely manner.
Job Responsibilities
- Perform Annual Product Quality Reviews (APQRs) compilation as assigned. This includes the following at minimum, as per SOP:
- 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 / WI s.
- 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.
- Co-ordinate 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.
- Responses 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.
- Works in a protected manner collaborating as a team member to achieve all outcomes.
- 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.
Job Requirements
- Education
- B. Pharm/ M. Pharm/ M.Sc
- Knowledge, Skills and Abilities
- Identify system improvement opportunities for data gathering, template content/format, process efficiency.
- Expert knowledge of SAP transactions used to support the Product Review process.
- Ensure timely communication of findings to the key business areas.
- Maintain the tracking system for compilation and review of assigned APQRs.
- Ensure that the annual product reviews are performed in full compliance with current procedures.
- Expert knowledge of International regulatory requirements that apply to Product Reviews.
- Demonstrated cGMP knowledge.
- Excellent technical writing, communication skills and interpersonal skills.
- Experience
- Minimum 3-6 years in the pharmaceutical industry with an emphasis on Quality Assurance.
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