QC S&T Analyst
2 weeks ago
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.
Tell employers what skills you have
CAPA
Business Continuity
Technology Transfer
GMP
Chemistry
Protocol
Biology
Project Timeline
Equipment Qualification
LIMS
Change Control
Laboratory
Writing Skills
EHS
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