Purpose: The primary role is to ensure smooth QC operational activities support to routine or new product introduction per cGMP/EHS/Regulatory expectations with global/site standards. Enables QC functional operational readiness, infrastructure/instrumentation support and compliance readiness.
Major Responsibilities:
Team Support
- Responsible for supporting QC micro-operations by timely conduct of test/release of routine or new product introduction activities.
- Develops technical competency and jointly creates a great place to work in.
Financial Support
- Supports financial spending are within the latest best estimates.
Compliance (Quality and Safety)
- SME for QC Micro - Operational readiness (Eg: Environment, Utilities and Product test), infrastructure/instrumentation needs and compliance readiness (Eg: Track & Trend) against cGMP/EHS/Regulatory compliance expectations to global/site procedures.
- Authors/Reviews lab documentation per cGMP or EHS expectations of the global/local site procedural needs.
- Support in resolution of manufacturing/laboratories investigation or exceptions for timely closure or issue resolution.
- Support in internal/external audits and enables audit response for a successful outcome in sustaining licenses to operate.
Infrastructure & Instrumentation
- Supports QC function infrastructure/instrumentation needs through supporting PM/CAL or Technological refresh needs.
New Product Introduction, Projects & Continuous Improvement
- Support in New Product Introduction (Small molecule or Biologic product) are conducted (TMT, Eqmt qualification) and delivered to enable a successful / timely program launch.
- Any other task/projects assigned by line manager.