Quality Validation Specialist, Breda, Noord-Brabant

Company Overview
This company is a leading global pharmaceutical organization committed to maintaining the highest standards of quality, compliance, and patient safety across its manufacturing operations.

Role Description
The Quality Validation Specialist provides QA oversight for validation activities related to manufacturing equipment, automation, computerized systems, and labeling operations. The role ensures validation, risk management, and change control processes comply with GMP, corporate policies, and regulatory requirements.

Responsibilities
- Oversee validation of equipment, automation, computerized systems, and packaging/labeling line controls.
- Review and approve validation documentation (IQ/OQ/PQ), protocols, reports, and technical change controls.
- Provide guidance on validation strategies, system design, and process characterization.
- Participate in quality risk management activities (e.g., FMEA).
- Ensure compliance with Annex 11, 21 CFR Part 11, and GMP standards.
- Collaborate cross-functionally to maintain inspection readiness and continuous compliance.

Requirements
- Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology, or related field.
- 5–8 years of experience in a GMP-regulated pharmaceutical environment.
- Experience with packaging equipment qualification, including IQ/OQ/PQ execution and compliant testing.
- Hands-on experience with labeling systems, including packaging-line controls, serialization, vision systems, coding/marking, and related automation.
- Strong knowledge of computerized system validation aligned with Annex 11 and 21 CFR Part 11.
- Familiarity with risk management tools and validation documentation practices.
- Strong analytical skills and effective communication abilities.
 

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