Quality Assurance Specialist

Candidate with strong QA background in API/Bio manufacturing plant and experience in external inspection management and internal audit

Main responsibility/scope:

• Conduct Internal audit, audit CAPAs follow-up (discussion of response) and management of open audit CAPAs
• Support external inspections (logistics and backroom support)
• Quality review of documents related to Data Integrity (Audit trail review, data integrity risk assessment, ERES assessment, Data Mapping)
• Support for other areas (Quality risk management, QMR tasks and regulatory submission) in terms of management of open tasks, revision/routing of documents
• Event organization and/or other administrative tasks as assigned by Manager/Delegate.

Requirements:

• Experiencein internal audit and external inspection
• Atleast 6 years experience in GMP manufacturing operations (API/Biomanufacturing)
• 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
• Teamplayer