QA Specialist

Quality Assurance Specialist
Location: Leiden
Sector: Biotechnology
Reference: 26370
We are looking for a Quality Assurance Specialist to support our Quality Management System (QMS) and ensure that products and processes meet internal and regulatory standards. In this role, you will work closely with cross-functional teams to manage quality documentation, support investigations, and drive continuous improvement. You will review and approve GMP documentation, support deviations and CAPAs, and play a key role in maintaining compliance within daily operations.
This position is essential in sustaining GMP compliance, supporting manufacturing activities, and helping drive operational excellence across the site.
What you’ll do

• Maintain and improve the Quality Management System (QMS)
• Review and approve GMP documentation (SOPs, batch records, work instructions)
• Support deviation investigations, CAPAs, and change control processes
• Assist internal and external audits and follow-up on findings
• Support documentation integrity, traceability, and record management
• Participate in root cause analysis and quality investigations
• Provide quality support to cross-functional teams (Manufacturing, QC, Engineering, Regulatory)
• Contribute to continuous improvement initiatives and quality training

What you bring

• Bachelor’s degree in Life Sciences, Engineering, or related field
• Experience working in a GMP-regulated environment (pharma, biotech, medical devices)
• Strong understanding of QMS and regulatory guidelines (e.g., GMP, ISO)
• Experience with deviations, CAPA, and change control
• Excellent documentation and communication skills
• Analytical mindset and attention to detail

Nice to have

• Experience supporting audits and regulatory inspections
• Knowledge of risk management tools (RCA, FMEA)
• Familiarity with electronic QMS systems
• Experience in clinical or commercial manufacturing environments

Practical Information
Start date: 01/02/2026
Contract Type: Temporary
Work Setup: Onsite
Teams: QA, Manufacturing, QC, Engineering, Regulatory
Interested?
Send your CV to s.jetten@panda-int.com
or call +31 20 204 4502 for more information