Quality Assurance Specialist
External
Index Career Consultants · SingaporePrepare for this interview
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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
Additional Information
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.
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Company Intel
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