Compliance Specialist
External
Antaes Asia · One Marina Boulevard, SingaporePrepare for this interview
EliteAI-generated questions, company research, and talking points tailored to this role
About the role
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 - Excellent communication skills, both written and verbal, in English
Your Match
How well this role fits your profile.
Company Intel
What employees say
Worked at ANTAES ASIA PTE. LTD.? Share your experience