Compliance Specialist

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 :