Senior Quality Assurance Operations Specialist

Job description

Band Level 3 Job Description Summary: The Senior QA Operations Specialist is responsible for providing quality assurance support for drug substance manufacturing activities, with a strong focus on batch record review and GMP compliance. The role ensures timely and compliant batch release, supports investigations and audits, and contributes to maintaining the Novartis Quality Management System. Job Description: This position is a temporary, activity‑based role and is limited to a fixed term of two years. Key Responsibilities: - Review and approval of batch manufacturing records as part of the batch release process - Review and assessment of analytical results, certificates, and specifications - Control and verification of batch documentation and quality records - Support audits, inspections, and regulatory interactions, investigations related to deviations, OOS/OOE, and complaints - Support CAPA management activities and changes to processes, documentation, and quality requirements - Preparation and review of certificates, reports, and quality-related lists - Communication and coordination with internal departments and external partners - Execution of tasks in a timely, efficient, a...