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