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 exceptions to ensure timely closure.
- Provide support during internal and external audits, contributing to successful audit outcomes and sustaining licenses to operate.
- Support QC infrastructure and instrumentation needs, including preventive maintenance, calibration, and technological refresh projects.
- Contribute to new product introduction activities (e.g., biologics, equipment qualification) to enable successful and timely program launches.
- Perform any other tasks or projects assigned by the line manager.
Job Qualifications / Minimum Requirements
- Bachelor's degree in Sciences (Biological, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, or Engineering (Biomedical, Chemical, Pharmaceutical), or equivalent.
- Strong analytical thinking with problem-solving and technical writing skills.
- Self-motivated and able to work independently.
- Solid knowledge of GMP and experience in laboratory operations.
- Effective collaborator with cross-functional teams.
- Ability to work within timelines and meet deadlines.
