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Compliance Specialist

Compliance Specialist

ANTAES ASIA PTE. LTD.D01 Cecil, Marina, People’s Park, Raffles Place, SG
21 days ago
Job description

Roles & Responsibilities

Job Description :

  • Contribute to Life Science projects for Antaes Asia clients
  • Lead and execute projects related to Data Integrity (DI), including audit trail review and data mapping of critical processes.
  • Support the implementation of data governance principles across OT / IT systems including DeltaV, MES, LIMS, and SAP.
  • Identify gaps and propose mitigation plans related to data lifecycle and system interface compliance.
  • Conduct internal audits as per site audit schedule.
  • Lead or support CAPA follow-up activities, including discussions on responses and management of open audit items.
  • Maintain internal audit documentation and track CAPA effectiveness.
  • Act as Compliance Partner for inspection readiness across functions, ensuring the site is in a constant state of preparedness.
  • Provide logistics and backroom support during external inspections (e.g., FDA, EMA, HSA).
  • Coordinate collection and routing of documents and responses during inspections.
  • Support key compliance programs including Quality Risk Management (QRM), Quality Plan, Quality Management Review (QMR), and regulatory submission activities.
  • Ensure timely management and closure of assigned tasks, routing of documents, and follow-up with stakeholders.
  • Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Requirements :

  • Diploma / Degree in Life Science, Chemical Engineering, Science or equivalent
  • Minimum 3-5 years of pharmaceutical, biopharmaceutical experience in Quality and / or Compliance (GMP) environment (preferably API / Biotech)
  • Strong Knowledge in OT and IT systems (DeltaV, MES system, SAP, LIMS etc) and system interface
  • Strong knowledge in Data integrity and Data governance principles
  • Quality and Compliance mindset
  • High adaptability and ability to lead and work with cross functional team
  • Strong communication and writing skills
  • Excellent communication skills, both written and verbal, in English

    • Tell employers what skills you have

    Excellent Communication Skills

    CAPA

    Quality Management

    Risk Management

    Routing

    Data Governance

    Adaptability

    Preparedness

    LIMS

    Audits

    Writing Skills

    Audit

    Chemical Engineering

    Mapping

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    Compliance Specialist • D01 Cecil, Marina, People’s Park, Raffles Place, SG