Primary Role
The role is responsible for ensuring smooth Quality Control (QC) operational activities to support routine testing or new product introductions in line with cGMP, EHS, and regulatory expectations. It focuses on enabling QC functional readiness, infrastructure and instrumentation support, and compliance activities.
Major Responsibilities
Support QC operations by conducting timely testing and release for routine and new product introduction activities. Develop technical competency as a trainer or buddy for new joiners, fostering a collaborative work environment. Act as Subject Matter Expert (SME) for QC operational readiness (e.g., raw material, IP, API/BDS testing), infrastructure/instrumentation needs, and compliance readiness (e.g., track and trend) against cGMP/EHS/regulatory requirements. Author and review laboratory documentation in accordance with global and local procedural standards. Assist in resolving manufacturing or laboratory investigations and excepti...