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