Responsibilities:
- Supports team task to support laboratory operation and infrastructure in the areas of examples: Equipment, Data Systems, Method) needs
- Participates in the management of laboratory equipment and computerized systems in QC laboratory to ensure business continuity and system data maintenance e.g., Empower, LIMS, SAP and equipment maintenance/calibration is in a state of compliance
- Participates in method technology transfer and laboratory equipment technological refresh/introduction activities into QC Laboratory within project timeline
- Participates in QC laboratory long range planning to ensure laboratory infrastructure needs is secured and Data integrity plan is in place to support business and laboratory compliance
- Author and execute qualification and equipment qualification documentation / method transfer (E.g.: Reports, Protocol, change control, related quality documents or procedures) are in cGMP compliance to corporate/site or regulatory requirements
- Supports and ensure timely escalation/handling of lab events or related quality actions. (E.g.: NCR, Lab Investigation, CAPA)
- Supports preparation and participate in internal/external audit, audit responses, to enable a successful audit outcome
- Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable. Lead/supports CI initiatives to enable laboratory performance metrics
- Carry out any other task as assigned by Line manager
About You:
- University Degree in Science related discipline (E.g.: Chemistry, biology, pharmaceutical sciences, or equivalent experiences)
- Minimum 1 - 3 years of pharmaceutical experience in a Quality Control Function
- Experienced in Regulatory/ Pharmaceutical requirements
- Analytical thinking with basic problem solving and writing skills
- Motivated and independent
- Basic GMP knowledge/Experience on QC Lab Equipment and Method transfer
- Good communication skills and Strong ability to work cross functional teams
- Ability to work towards timeline
- Based in Tuas
Job Type: Contract
Contract length: 12 months. Option to extend/convert subject to performance review.
