Specialist, Quality Operations

·       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