Our client is looking for a QA Specialist who will play a key role in ensuring GMP compliance across equipment, automation, and information systems. In this role, you will support validation activities, guide operational teams on quality requirements, and act as a subject-matter expert in core QA processes such as change control and quality risk management.
What You’ll Do
- Provide QA support and oversight for validation of equipment, automation, and information systems.
- Review and approve validation documentation, ensuring compliance with Corporate, Site, and Regulatory standards.
- Align on validation strategies together with PD, Maintenance & Engineering, and IS teams, providing clear guidance on design, characterization, and validation activities.
- Review and approve equipment-related changes (e.g., parameter updates, like-for-like assessments).
- Review and approve changes to M&E procedures, including changeover processes and maintenance activities
- Manage device-related responsibilities and ensure alignment with all relevant GMP regulations.
- Represent QA in QRM activities such as pFMEA, QRAES, and computer system compliance.
- Ensure site-level Quality Risk activities align with corporate policies and strategy.
- Review and assess QRM reports.
- Perform final QA review of technical change controls, ensuring stakeholder assessments are complete and accurately documented
- Act as QA Subject Matter Expert, collecting input from multiple QA areas to provide a complete QA assessment for technical changes.
- Master degree in Engineering, Pharmaceutical sciences, Process Technology or equivalent
- 5-8 years of professional experience in GMP environment
- Relevant experience in Equipment and Automation Validation
- Proven experience with GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11).
- Proven experience with risk management tools such as FMEA, etc.
- Proven experience with statistical tools to support e.g. Sampling plans and hypothesis testing.
- A challenging work environment with excellent career development programs.
- Hybrid position, but at least 3 times per week on site in Breda.
- For this role, the company offers a competitive salary package.
- Reimbursement of travel expenses is dependable on travel distance.
- The contract will be through Undutchables.
Salarisomschrijving
€6200.00 - €6200.00 monthly