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:

• 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