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

- Excellent communication skills, both written and verbal, in English