Compliance Specialist

Job Description: - Contribute to Life Science projects for Antaes Asia clients - Conduct internal audits and support internal audit CAPAs follow-up (discussion of response) and management of open audit CAPAs - Serve as Compliance Partner for inspection readiness for assigned department - Support external inspections(logistics and backroom support) - Conduct training for data integrity and review documents related to Data Integrity (Audit trail review, Data Integrity Risk Assessment etc) - Support for other areas(Quality risk management, Quality Plan, QMR tasks and regulatory submission) in terms of management of open tasks, revision/routing of documents - 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 4-6 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