Responsibilities:
- 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
About You:
- Experience in internal audit and external inspection
- At least 6 years of experience in GMP manufacturing operations (API/Bio manufacturing)
- Strong knowledge in Engineering operations, 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
- Team player
Date range: Start mid Jul 2026.
Duration: 6 months. Option to extend depending on performance and business needs.
