Opportunity to Join Novartis as Quality Operations Associate Analyst

Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post : Associate Analyst - Quality Operations

Job Description
Accountability is related to handling of Annual Product Quality Reviews (APQR). Annual Product Quality Review: Extract data from relevant sources 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.

Responsibilities
• Collect contributory reports for product related evaluations. Interact with Suppliers and / or manufacturing sites as required.
• Support in updating and maintenance of APQR schedule as required. Compile and review of APQR report/ data as applicable to ensure it is complete and correct.
• Ensure completion of APQRs within defined timelines. Archival of the approved APQRs as applicable. Communicate with external suppliers to provide applicable approved supplier APQR and related documents to QOP.
• Inform respective stakeholders/QAMs if there is any delay in receiving PQR and related documents from suppliers and External laboratories and take necessary actions. Support in volume distribution and tracking of APQRs till its approval.
• Update approved APQR data in e-compass file followed by interpretation of data to conclude product robustness.

Candidate Profile
• Bachelor’s or master’s degree in related technical discipline or equivalent experience demonstrated.
• Professional Experience: 1-3 years in Quality. Support the maintenance of the Country Quality Review (MAH/BRS) schedule. Coordinate with NCQ SPOCs and relevant manufacturing, packaging, testing, or batch releasing sites to facilitate drafting of the Country Quality Review forms.
• Extract and compile required data from relevant sources in line with the predefined format for Country Quality Reviews. Perform interpretation and consolidation of the compiled data.
• Review the compiled information for accuracy and completeness. Submit the finalized Country Quality Reviews to the respective Country Quality teams for approval.
• Ensure appropriate archival of approved Country Quality Review documents, as applicable.

Additional Information
Experience : 1-3 years
Qualification : Bachelor’s or master’s degree
Location : Hyderabad (Office)
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Operations
End Date : 30th September 2026