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