Talent.com
Deze vacature is niet beschikbaar in je land.
Quality Assurance Specialist – Pharmaceutical Manufacturing

Quality Assurance Specialist – Pharmaceutical Manufacturing

Meet Life SciencesLeiden, South Holland, Netherlands
26 dagen geleden
Functieomschrijving

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!

    Maak een vacature-alert aan voor deze zoekopdracht

    Quality Assurance Specialist • Leiden, South Holland, Netherlands