Jobid: 3202926850 (0.11)
Overview
As CSV and Quality Lead, you drive the delivery of CSV and Quality services across manufacturing IT projects. You’ll develop CSV competence and mentor analysts, ensuring alignment with MSD AH Quality Management System. Your role focuses on standardizing CSV methods, planning validation, and overseeing change control for regulated computer systems. You will collaborate across IT and manufacturing networks to foster a customer centric, compliant operating model. This position offers the chance to shape validation practices and support scalable, quality-driven solutions in an international context.
Verantwoordelijkheden
- Drive standardization and adherence to CSV methodologies across project teams based on global standards
- Lead validation planning and design efforts and provide oversight to CSV analysts
- Support quality oversight of change control and validation activities for regulated computer systems (21 CFR Part 11)
- Promote collaboration with other IT divisions and the wider manufacturing network to foster a collaborative, customer-centric culture
Belangrijkste vereisten
- Bachelor’s degree with relevant experience in Computer Science or Computer Science Engineering or equivalent
- At least 5 years in a highly regulated manufacturing environment (pharma, biotech, food, or chemicals)
- At least 3 years of proven CSV experience
- Understanding of GxP and validation requirements
- Certified in xxx methodologies
- Experience with digital tools to support validation (preferred)
- Strong interpersonal and written English (Dutch preferred)
- Resident near Boxmeer, Netherlands (relocation not offered)
- effective interpersonal communication
- collaboration
- customer-centric mindset
- CSV methodologies
- validation planning and execution
- change control
Deel deze vacature: