Quality Compliance Specialist - Part-Time

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.