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