Quality Compliance Specialist

2 weeks ago

Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time
Roles & Responsibilities

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
Tell employers what skills you have

MES
Quality Management
Information Management
GMP
Risk Management
Data Governance
Manufacturing Operations
Adaptability
LIMS
Audits
Regulatory Submissions
Laboratory
Manufacturing
Writing Skills
Audit
Mapping

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