Qc Analyst

5 days ago

Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time

**Responsibilities**:

- Supports team task to enable adequate resources to support laboratory infrastructure (E.g.: Equipment, Method, System) needs
- Participates in 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
- 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 or Review (If assigned) 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/ 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 Supervisor

**About You**:

- University Degree in Science related discipline (e.g. chemistry, biology, pharmaceutical sciences, or equivalent experiences)
- Minimum 2 - 4 years of pharmaceutical experience in a Quality Control Function
- Experienced in Regulatory/ Pharmaceutical requirements
- Analytical thinking with problem solving and writing skills
- Motivated and independent
- GMP knowledge on QC Lab Equipment and Method transfer
- Good communication skills and Strong ability to work cross functional teams
- Ability to work towards timeline

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

**Salary**: $3,500.00 - $5,500.00 per month

**Experience**:

- Regulatory/ Pharmaceutical: 2 years (preferred)
- Quality Control Function: 2 years (preferred)

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