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Compliance Specialist
ANTAES ASIA PTE. LTD.
Singapore
23 days ago
Job description
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
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