QA Specialist, Breda, Noord-Brabant

The Company
A global biotechnology organization focused on science-driven innovation and the production of high-quality medicines. The company operates in a highly regulated, state-of-the-art manufacturing environment and promotes a culture of quality, collaboration, and continuous improvement.

Role Description
As a QA Specialist, you provide Quality Assurance oversight for equipment, automation, computerized systems, and labeling & packaging equipment within a GMP-regulated pharmaceutical environment. You ensure that validation, change management, and risk management activities comply with corporate, site, and regulatory requirements. As a QA subject matter expert, you support the compliant design, qualification, and lifecycle management of manufacturing and packaging systems.

Responsibilities
- Provide QA oversight for equipment, automation, and computerized system validation
- Review and approve validation protocols and reports to ensure GMP and regulatory compliance
- Provide QA support for labeling and packaging equipment validation and changes
- Guide operations and engineering teams on quality policies, procedures, and compliance standards
- Support testing strategies and quality investigations
- Review and approve equipment and process changes, including parameter and like-for-like changes
- Review and approve maintenance and engineering procedures (preventive and corrective)
- Ensure GMP compliance for device and combination product activities
- Represent QA in Quality Risk Management activities (e.g., FMEA, QRA, computer system compliance)
- Act as QA SME for validation and technical change activities

Requirements
- Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology, or a related field
- 5–8 years of QA experience in a GMP-regulated pharmaceutical environment
- Strong experience in equipment and automation validation
- Hands-on QA experience with labeling and packaging equipment (essential)
- Experience with computerized system validation (CSV), Annex 11, and 21 CFR Part 11
- Solid knowledge of GMP and regulatory compliance in pharmaceutical manufacturing
- Practical experience with risk management tools (e.g., FMEA, QRM)
- Experience applying statistical tools for sampling and testing

Other information
If you are interested and want to apply, please submit your application via the apply button below and contact me.

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