QA Specialist - Equipment Validation, Breda, Noord-Brabant

The Company
Our client is a global biotechnology leader dedicated to advancing innovative therapies that improve patient outcomes worldwide. With decades of scientific excellence, the organization focuses on developing cutting-edge biologics and breakthrough medicines supported by state-of-the-art manufacturing facilities. The company fosters a culture rooted in quality, integrity, and continuous improvement, driving meaningful impact in healthcare across multiple therapeutic areas.

Role Description
As a QA Operations Specialist, you will play a key role in ensuring high standards of quality and compliance across equipment, automation systems, and validation activities within a GMP-regulated environment. You will oversee validation processes, support engineering and operations teams, and contribute to quality investigations and risk management activities. In this role, you will act as a subject-matter expert, ensuring all systems, processes, and documentation meet regulatory, corporate, and industry requirements. This position requires strong analytical capabilities, a structured mindset, and the ability to collaborate across multiple technical disciplines.

Responsibilities
- Provide QA oversight for validation of equipment, automation, and information systems.
- Review and approve validation documents, ensuring alignment with site, corporate, and regulatory expectations.
- Support the development of validation strategies in collaboration with cross-functional teams.
- Review and approve equipment modifications, parameter updates, and like-for-like assessments.
- Approve updates to maintenance procedures, including preventive and corrective activities.
- Manage responsibilities related to device and combination product quality, ensuring alignment with GMP and global quality standards.
- Represent QA in QRM processes such as pFMEA, QRAES, and computer system compliance assessments.
- Ensure site risk management activities align with corporate policies and regulatory expectations.
- Review and endorse quality risk assessment reports.
- Conduct final QA reviews of technical change controls, validating completeness and accuracy.
- Act as QA SME, gathering insights across QA functions to deliver risk-based, compliant assessments.

Requirements
- Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology, or related field.
- 5–8 years of experience in a GMP-regulated environment.
- Strong background in equipment and automation validation.
- Solid understanding of GMP regulations, computer system compliance (Annex 11, Part 11), and validation best practices.
- Experience with risk management tools such as FMEA.
- Knowledge of statistical tools for sampling strategies and hypothesis testing.

Other Information
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