Responsibilities:
- As a quality point of contact to manage change control plans for projects Driving change control plan from initialization to execution and closure in accordance with project schedule.
- Quality review of documents related to Data Integrity (Audit trail review, data integrity risk assessment, ERES assessment, Data Mapping)
- Support Internal audit, audit CAPAs follow-up (discussion of response) and management of open audit CAPAs (if required)
- Support external inspections (logistics and backroom support)
- 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.
About You:
- Experience in GMP manufacturing operations in biopharmaceutical environment.
- Experience in change control management and data integrity is preferred.
- Strong knowledge in Data integrity and Data governance principles
- Strong Quality and Compliance mindset
- High adaptability and ability to lead and work with cross functional team
- Strong communication and writing skills
- Team player
Duration: 6 months. Option to extend depending on business needs.
