Senior Qc Analyst

1 week ago


Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time

**Responsibilities**:

- Supports by conducting team training to enable adequate resources to support laboratory infrastructure (E.g.: Equipment, Method, System) needs
- Lead/Supports the management of laboratory equipment and IT systems in QC laboratory to ensure business continuity and system data maintenance, equipment maintenance/calibration is in a state of compliance
- Lead/Supports method technology transfer and laboratory equipment technological refresh/introduction activities into QC Laboratory within project timeline
- Lead/Supports 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 or Review method transfer/qualification and equipment qualification documentation (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)
- Acts as QC SME to support 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 and act as designee of Supervisor (as assigned)

**About You**:

- University Degree in Science related discipline (e.g. chemistry, biology, pharmaceutical sciences, or equivalent experiences)
- Minimum 4 - 6 years of pharmaceutical experience in a Quality Control Function
- Experienced and knowledgeable in Regulatory/ Pharmaceutical requirements
- Strong analytical thinking with good problem solving and writing skills
- Motivated and independent, a role model to the team
- Strong GMP knowledge on QC Lab Equipment and Method transfer
- Good communication skills and Strong ability to work cross functional teams
- Ability to work under pressure

**Job Type**: Contract
Contract length: 12 months

**Salary**: $4,000.00 - $7,000.00 per month

**Experience**:

- Quality Control Function: 4 years (preferred)



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