- Support departmental internal quality Audit and participate in external quality audit, co-ordinate on audit reply, and to follow- up on execution of preventive and corrective action (CAPA).
- Manage engineering regulatory/GMP-related documentation
- Ensure strict adherence to Good Manufacturing Practices (GMP)/PICs guidelines by closely monitoring, observing, and continuously improving.
- Coordinating and execution of training & re-training program, preparing training schedule, materials, and assessment (SOP, WI, & GMP).
- Coordination of calibration of critical systems and instruments with third-party vendors
- Degree in Engineering or equivalent
- Minimum 2 years of relevant experience in the pharmaceutical industry