The QA Specialist is responsible for maintaining and improving the Quality Management System (QMS) within a GMP-regulated pharmaceutical environment. The role supports product launches, supplier qualification, audits, change control, system validation, and complaint handling. The position also includes writing and reviewing GMP documentation and Product Quality Reviews, as well as contributing to quality planning and compliance activities.
Non-Negotiable Skills, Qualifications, and Experience
- Bachelor’s degree in Life Sciences, Engineering, or a comparable scientific/technical field
- Minimum 5 years of experience in a GMP-regulated environment (pharmaceutical, biotech, or medical devices)
- Demonstrable experience working with GMP regulations
- Demonstrable experience working with GDP regulations
- Experience handling deviations in a GMP environment
- Experience managing CAPA processes
- Experience managing change control processes
- Experience writing and reviewing GMP documentation (e.g., SOPs, work instructions)
- Experience supporting audits or self-inspections
- Experience with supplier qualification activities
- Professional proficiency in Dutch (written and spoken)
- Professional proficiency in English (written and spoken)
Desirable Skills, Qualifications, and Experience
- Experience in pharmaceutical manufacturing of generic medicines
- Experience contributing to Product Quality Reviews
- Experience with data integrity projects
- Experience with system validation activities
- Experience coordinating or delivering GMP training
- Experience in permit/license management within a regulated environment
- Experience working in cross-functional or project teams
- Leadership experience
What the Role Offers:
- QA Specialist position within a GMP-regulated pharmaceutical manufacturing environment
- Responsibility for maintaining and improving the QMS, including deviations, CAPAs, change controls, and supplier qualification
- Involvement in audits, system validations, Product Quality Reviews, and new product launches
- Permanent position with long-term growth perspective
- Competitive salary, 28holidays (full-time), and 8% holiday allowance
What the Assignment Offers:
- QMS Specialist role focused on GMP compliance, batch review, and quality event management
- Direct responsibility for deviations, CAPAs, change controls, and CMO oversight
- Exposure to EU-regulated pharmaceutical release activities
- 6–12 month freelance contract with strong extension potential
- Clear operational scope in a production-driven environment
- Immediate impact on quality performance and audit readiness
- Interested in discussing this opportunity confidentially?
Maurits van Sloun
? m.vansloun@panda-int.com
? +31 20 204 4502