Job Summary
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