The posting
Main Responsibilities:
- Conduct training for data integrity (site wide refresher and NEO training) and review documents related to Data Integrity (Audit trail review, and Data Integrity Risk assessment etc)
- 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 (such as hot topic rehearsal with SMEs and storyboard)
- Support external inspections (logistics and backroom support)
- 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:
- At least 6 years QA experience in GMP manufacturing operations (API/Bio manufacturing) required, preferably in Quality Operations/Compliance
- Experience in internal audit and external inspection preferred
- Knowledge in Data integrity and Data governance principles required
- Strong knowledge in Engineering operations, OT and IT systems (Deltav, MES system, SAP, LIMS etc) and system interface preferred Quality and Compliance mindset required
- High adaptability and ability to lead and work with cross functional team required
- Strong communication and writing skills required
- Team player required Contract Duration: 12 months contract



