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.
