QA Validation Specialist, Breda, Noord-Brabant

Company Description:
A global biotechnology company committed to developing innovative therapies that improve patients’ lives. With a focus on science and quality, the organization operates in a highly regulated environment and values collaboration, integrity, and continuous improvement across all functions.

Job Description:
We are seeking a detail-oriented QA / Validation Specialist to support the validation of equipment, automation systems, and computer systems in a GMP-regulated environment. This role involves reviewing validation documentation, providing guidance to operations, supporting quality engineering activities, and ensuring compliance with regulatory standards. The specialist will also participate in risk management processes and help maintain high-quality standards across multiple smaller projects.

Responsibilities:
- Develop and implement validation strategies for equipment, processes, and computerized systems, ensuring compliance with GMP requirements.
- Perform and review IQ/OQ/PQ for lab, cleanroom, packaging, labeling, and assembly equipment.
- Support maintenance and engineering changes, including approvals for parameter adjustments, procedural updates, and equipment revalidation.
- Manage device-related responsibilities, ensuring compliance with GMP regulations for combination products.
- Participate in Quality Risk Management activities, including risk assessments, compliance reviews, and supporting root cause investigations.
- Conduct final reviews of technical change controls and ensure stakeholder assessments are completed accurately.
- Collaborate with cross-functional teams to provide QA input during validation, change control, and risk management processes.
- Support smaller validation or production projects in parallel without managing people directly.

Requirements / Qualifications:
- Master’s degree in Engineering, Biomedical, Pharmaceutical Sciences, Process Technology, or a related field.
- 3–6 years of experience in a GMP-regulated environment, with hands-on equipment validation (packaging, labeling, assembly, lab equipment) and CSV experience.
- Strong QA mindset with experience handling deviations, SOPs, CAPA, and risk-based decision-making.
- Knowledge of GMP regulations, including Annex 11 / 21 CFR Part 11 and GAMP 5 guidelines.
- Experience with risk management tools (e.g., FMEA) and statistical techniques for sampling and data analysis.
- Excellent analytical, communication, and documentation skills.
- Ability to work across teams, handle multiple smaller projects, and provide guidance to operations without managing staff.
    
Other Information:
If you are interested in this opportunity, please apply via the application link and feel free to contact me for more information.

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