Quality Compliance Specialist

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