QA Specialist – Pharmaceutical Quality Operations
Location : Leiden, Netherlands (Hybrid – Minimum 3 days on-site)
Industry : Pharmaceuticals & Biotech
Employment Type : Full-time, Permanent
About the Role :
We are supporting a fast-growing pharmaceutical company in hiring a QA Specialist to strengthen their Quality team at a key operational site in the Netherlands. This facility plays a vital role in the development and supply of essential medicines across Europe.
You’ll join a collaborative team focused on maintaining high-quality standards and compliance with EU GMP and GDP requirements. The successful candidate will take ownership of day-to-day QA activities while supporting ongoing improvements in quality systems, documentation, and audit readiness.
Key Responsibilities :
- Support the batch release process by reviewing manufacturing and testing documentation
- Manage and organise QMS documentation, including SOPs, forms, and regulatory files
- Maintain and update technical files and Quality Agreements
- Assist with health authority inspections, customer audits, and CAPA follow-up
- Review product artwork for regulatory compliance
- Collaborate closely with cross-functional teams including Regulatory Affairs, Supply Chain, QPs, and distributors
- Help ensure documentation is stored and maintained within SharePoint and other digital systems
Required Qualifications :
Bachelor's degree in Life Sciences or related field3+ years of Quality Assurance experience within the pharmaceutical industrySolid knowledge of EU GMP / GDP guidelines and quality system standardsProficiency with MS Office and digital document management tools (e.g. SharePoint)Fluency in Dutch and English (minimum C1 level)Preferred Qualifications :
5+ years’ experience in QA roles, ideally within a GMP manufacturing environmentPrior experience supporting audits, inspections, and regulatory documentationStrong understanding of quality documentation systems and batch release processesPositive, collaborative mindset with a proactive and independent approachAdditional Information :
Hybrid working model : minimum 3 days on-site , 2 days remoteReporting line : Site Head QPStandard Monday–Friday scheduleOccasional travel to the UK may be requiredThis is an excellent opportunity to join a forward-thinking pharmaceutical organisation and make a meaningful impact within a dynamic QA team. If you’re an experienced Quality Assurance professional ready to take ownership and grow in a collaborative environment - apply today!