* please only apply if you are located in Netherlands*
JOB'S MISSION
- Responsible for Santen EMEA Regional Quality Governance Activities to ensure that EMEA Quality Management System (QMS) processes are working properly and continuous improvement is achieved.
- Responsible for EMEA Quality Audit Management. Roll out of consolidated supplier risk assessment and audit plan (CMO, API,GDP,ISO).
- Support EMEA Learning Management System activities including GxP/ISO Training.
- Play key role in quality management system related activities to ensure continuous compliance of Santen EMEA to applicable EU pharma distribution (EU GDP, MDD/MDR, ISO13485)
KEY RESPONSIBILITIES & ACCOUNTABILITIES
In alignment with Santen vision and with EMEA Quality strategy, objectives and directions, and in compliance with any external or internal regulatory requirements:
- Be responsible for and support activities and projects related to the development, standardization, implementation, monitoring and continuous improvement of the EMEA Quality management system ensuring:
- Robust best-in-class, standardized policies, procedures, guidelines and models.
- Effective and efficient roll-out and monitoring across all EMEA entities.
- Responsible for EMEA Quality Audit Plan to achieve:
Health Authority Inspection Readiness in EMEA
Qualified EMEA Auditor Pool
- To support quality operational tasks and cross-functional projects related EMEA Quality Management System (QMS) in connection with EMEA Director QMS and IT quality.
Essential
- Young Professionals welcome! (located in the Netherlands)
- B.Sc or M.Sc in chemistry, pharmaceutical, biotechnology, or life science area
- GxP experience and in-depth Quality Management System (QMS) knowledge
-
2+ year experience of working in pharmaceutical industry or related area
- e-QMS tools: VeevaVault, Trackwise
Desirable
- Enhanced IT system skills
- SAP
Santen SA, the Netherlands Branch has an exclusive arrangement for recruitment services. External recruiting agencies are kindly requested not to contact us regarding the positions listed here.
If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.
