Key Responsibilities:
- Review and approve validation documentation for equipment, processes, and systems.
- Ensure GMP compliance for equipment changes and provide QA guidance for technical assessments.
- Review and approve master data in the PASX electronic batch record system.
- Conduct final QA review of technical change controls and validate assessments from multiple stakeholders.
- Act as QA contact for deviation records and ensure compliance with quality standards.
- Manage device and combination product responsibilities, ensuring alignment with GMP regulations.
- MBO or Bachelor's degree in Life Sciences, Process Technology, or equivalent.
- Minimum 3 years in the pharmaceutical or medical device industry with a focus on equipment and automation validation.
- Strong understanding of GMP and a QA background.
- Relevant hands on equipment validation, label and packaging operations experience.
- Logical problem-solving, risk-based decision-making, and effective communication at multiple organizational levels.
- Fluency in English, both written and verbal.
- 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
€4700 - €5000 monthly