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:
- Responsible to support QC operations by timely conduct of test/release of routine or new product introduction activities.
- Develops technical competency as trainer/new joiner buddy and jointly creates a great place to work in.
- SME for Key QC Operational readiness (Eg: Raw material, IP, API/BDS 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.
- Supports QC function infrastructure/instrumentation needs through supporting PM/CAL or Technological refresh needs.
- Responsible for New Product Introduction (Biologic product, TMT, EQMT qualification) to enable a successful / timely program launch.
- Any other task/projects assigned by line manager.
Interested candidates please send in your updated resume in MS Word Format to:
[Confidential Information]
Subject: Clinic Administrator / Guest Relations
EA Personnel: Kate Leau Wei Xuan (R1552331)
Company Registration No.: 99C4599
