Quality Compliance Specialist

3 days ago


Tuas, Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time

**Main Responsibilities**:

- Conduct internal audits and support the follow-up of internal audit CAPAs (Corrective and
- Preventive Actions), including discussion of responses and management of open audit CAPAs.
- Serve as the Compliance Partner for inspection readiness in the Bio sector.
- Provide support for external inspections, including logistics and backroom support.
- Conduct training on data integrity and review related documents (e.g., audit trail reviews and data mapping of critical processes).
- Support other areas such as quality risk management, quality planning, QMR (Quality
- Management Review) tasks, and regulatory submissions by managing open tasks and revising/routing documents.

**About You**:

- Experience in internal audits and external inspections.
- Experience in GMP (Good Manufacturing Practice) manufacturing operations, specifically in Bio manufacturing.
- Strong knowledge of OT (Operational Technology) and IT systems, including DeltaV, MES (Manufacturing Execution System), SAP, LIMS (Laboratory Information Management System) and system interfaces.
- Strong knowledge of data integrity and data governance principles.
- Quality and compliance mindset.
- High adaptability and ability to lead and work with cross-functional teams.
- Strong communication, writing skills and a team player.

**Job Type**: Contract
Contract length: 6 months

Pay: $4,500.00 - $7,000.00 per month

**Benefits**:

- Health insurance

Schedule:

- Monday to Friday

**Experience**:

- internal audits: 1 year (preferred)
- QMR (Quality Management Review): 1 year (preferred)
- Pharmaceutical: 1 year (preferred)
- GMP/GDP Compliance: 1 year (preferred)

Work Location: In person



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