We are looking for a Quality Assurance Specialist to join our multinational Pharmaceutical/Biotechnology client based in Breda. This role involves providing QA support and oversight for validation processes related to equipment, automation, and information systems.

About the Company

Orion Group was established in 1987 and has grown to be one of the largest independent recruitment companies globally, with a network of 200 employees across 24 offices in 68 countries. We specialize in workforce solutions across various sectors including Oil & Gas, Life Science, Power & Utilities, Construction & Infrastructure, Manufacturing, and Renewables.

The Role

As a Quality Assurance Specialist, you will be responsible for:

• Performing QA support and oversight for validation of equipment, automation, and information systems.
• Reviewing and approving validation documentation to ensure compliance with Corporate, Site, and Regulatory requirements.
• Guiding operations staff regarding adherence to quality policies, standards, and procedures.
• Providing quality engineering support for testing strategies and quality investigations.

Responsibilities

• Conduct process, equipment, and IS validation.
• Collaborate with PD/M&E/IS to agree on validation strategies while ensuring GMP quality and compliance.
• Review and approve validation documentation.
• Support maintenance and engineering by reviewing and approving changes to equipment and M&E procedures.
• Manage device responsibilities and ensure compliance with GMP regulations.
• Represent QA in Quality Risk Management (QRM) activities and ensure alignment with corporate policies.
• Conduct final reviews of technical change controls and collect input from various QA areas.

Requirements

• Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology, or equivalent.
• 5-8 years of professional experience in a GMP environment.
• Relevant experience in Equipment and Automation Validation within the pharmaceutical industry.
• Familiarity with Nonconformances, CAPAs, and Change Control processes.
• Proven experience with GMP, equipment validation, and computer compliance (Annex 11, Part 11).
• Experience with risk management tools such as FMEA.
• Strong analytical skills to evaluate complex situations using multiple information sources.
• Effective communication skills across various levels and areas.
• Attention to detail and excellent writing skills.
• Good decision-making skills with a risk-based approach.
• Team player who collaborates constructively towards solutions.

If you are interested in this opportunity, please contact Tim Browaeys at tim.browaeys@orion-jobs.com or call him at 0044 7593448607.