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.
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• 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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Division
Operations
Business Unit
Innovative Medicines
Location
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No