Senior Projectmanager Capex Locatie

Specialist QA - Quality Assurance - Netherlands, Breda - September 1, 2026 - Fulltime - Wo - V-201935-1 - €80000 - €84000 per annum
- Providing QA oversight for the validation of equipment, automation and computerized/information systems ; - Reviewing and approving validation protocols, reports and other technical documentation; - Advising project and operational teams on validation strategy, system design and GMP compliance; - Reviewing and approving technical changes to equipment, parameters and engineering procedures; - Supporting Maintenance & Engineering with quality-related assessments for preventive and corrective maintenance activities; - Acting as QA Subject Matter Expert for technical Change Controls ; - Ensuring that stakeholder assessments and required actions within Change Controls are complete and correctly documented; - Representing QA during Quality Risk Management (QRM) activities, including FMEA and other risk assessments; - Reviewing Quality Risk Assessment reports and ensuring alignment with site and corporate quality requirements; - Supporting investigations, testing strategies and other quality engineering activities; - Supporting quality requirements related to devices and combination products .
You will work independently across multiple projects and assignments, determining the appropriate quality approach while ensuring agreed objectives and timelines are achieved.
What you bring - A Master's degree in Engineering, Pharmaceutical Sciences, Process Technology or a comparable technical/scientific discipline; - Approximately 5-8 years of professional experience within a GMP-regulated environment ; - Strong experience with equipment and automation validation ; - Experience with computerized system compliance and relevant regulations such as EU GMP Annex 11 and 21 CFR Part 11 ; - Good understanding of validation principles, qualification and Quality Risk Management; - Experience with risk management methodolo...