Summary
Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. Manage Quality aspects & projects within area of responsibility.
About The Role
- Support in updating and maintenance of APQR (Annual Product Quality Review) schedule.
- Perform review of APQR report/ data as applicable to ensure it is complete and correctness.
- Collect contributory reports for product related evaluations.
- Interact with CMOs and / or manufacturing sites as required.
- Complete APQRs within defined timelines.
- Extract data from relevant sources in IT tools/ applications.
- Interpret and compile external supplier APQR and/ or extracted data from Internal Novartis systems into a pre-defined template and draft conclusion of product quality review.
- Archive the approved APQR as applicable
- Communicate with external suppliers to provide applicable APQR to QOP.
- Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed
- Support in maintenance of MAH/BRS review / PQR schedule
- Coordinate with NCQ SPoCs and/ or manufacturing/ packaging/ testing/ batch releasing sites as required to draft MAH/BRS checklist
- Extract data from relevant sources and compile MAH/BRS as per the requirements in a predefined format
- Interpretation and consolidation of the data
- Review for accuracy and completeness of compiled data and/or information
- Submit the drafted MAH/BRS reviews for approval to respective Country/ team
- Archive the approved MAH/BRS review documents
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