Quality Assurance Specialist - Pharmaceutical Manufacturing

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 field
• 3+ years of Quality Assurance experience within the pharmaceutical industry
• Solid knowledge of EU GMP/GDP guidelines and quality system standards
• Proficiency 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 environment
• Prior experience supporting audits, inspections, and regulatory documentation
• Strong understanding of quality documentation systems and batch release processes
• Positive, collaborative mindset with a proactive and independent approach

Additional Information:

• Hybrid working model: minimum 3 days on-site, 2 days remote
• Reporting line: Site Head QP
• Standard Monday-Friday schedule
• Occasional travel to the UK may be required

This 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!