Senior QA Specialist – Equipment & Process Qualification, Leiden, Zuid-Holland

Company
The client is a well-established organization operating in a highly regulated production environment. They focus on delivering high-quality products and maintaining strong compliance standards across manufacturing and quality operations. The team works on complex site-based projects that support product introduction, process readiness, and continuous quality improvement.

Job Description
The client is looking for a Senior QA Specialist – Equipment & Process Qualification to support quality activities related to new product introduction and the qualification of equipment and processes. This role is based in Leiden and will suit someone with strong experience in quality assurance within a regulated environment, ideally linked to manufacturing or technical operations.
The successful candidate will work closely with cross-functional teams to help ensure that quality standards are met throughout qualification and implementation activities. This is a hands-on role for someone who is comfortable working in a fast-moving environment and contributing to key site projects.

Responsibilities
- Support quality assurance activities for new product introduction projects
- Provide QA oversight for equipment and process qualification work
- Review and support quality documentation linked to qualification and implementation activities
- Work closely with operational, technical, and quality stakeholders across the site
- Help ensure compliance with internal quality standards and regulatory expectations
- Contribute to a smooth and compliant introduction of new equipment, processes, or products
- Identify quality risks and support issue resolution during project execution

Requirements
- Experience in quality assurance within a regulated environment, ideally pharma or biotech
- Strong understanding of equipment and process qualification activities
- Experience supporting projects linked to product introduction or implementation
- Able to work effectively with cross-functional teams on site
- Strong communication skills in English
- Dutch is preferred

Other Information
This is a great opportunity for a quality professional who enjoys working in a practical, site-based role with strong exposure to qualification and implementation activities in a regulated setting.
If you are interested and want to apply, please submit your application via the apply button below and contact me.

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