Validation Specialist

7 dagen geleden


Breda, Nederland Panda International Voltijd

Are you energized by working in a dynamic, high-quality environment where your expertise directly protects patient safety? Lees de onderstaande informatie voor meer informatie over deze functie en solliciteer vervolgens om in aanmerking te komen. We’re looking for a hands-on, detail-oriented Specialist QA to support our Site Quality team with Equipment, Automation, and IS validation. In this role, you’ll be the QA link between Engineering, Operations, and Validation activities. From reviewing validation strategies to approving equipment changes and supporting risk assessments, you’ll ensure our systems and processes always meet the highest GMP standards. What You’ll Do Guide validation activities: Review and approve validation strategies and documentation for equipment, automation, and IS. Support Engineering & Maintenance: Approve equipment changes, updates to procedures, and maintenance processes. Be the QA partner for new setups: Provide oversight during new line implementations or facility expansions. Lead Quality Risk Management: Represent QA in FMEA, QRAES, and computer compliance activities. Own QA change control: Perform final QA assessments for technical change controls. Strengthen quality culture: Apply risk-based thinking and contribute to continuous improvement. Requirements Master’s in Engineering, Pharmaceutical Sciences, Process Technology, or similar. 5–8 years in a GMP environment. Strong experience in Equipment & Automation Validation (min. 4 years). Knowledge of GMP, Annex 11/Part 11, and validation/IS compliance. Experience with QRM tools (FMEA) and statistical methods. Strong analytical, communication, and writing skills. Xnkfpon Interested? Send your CV to or apply now


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