🚀 FREELANCE QA Specialist – Process & Cleaning Validation (GMP)
📍 Antwerp, Flemish region, Belgium| 💼 FREELANCE - CONTRACT |
🏭 Pharmaceutical Environment | DUTCH language REQUIREMENT
🔎 Role Overview
We are currently looking for a QA Specialist with strong expertise in process and cleaning validation to support activities within a GMP-regulated pharmaceutical environment.
In this role, you will play a key part in ensuring that validation activities meet quality standards and regulatory requirements, while supporting both new product introductions and ongoing lifecycle validation.
🎯 Key Responsibilities
* Provide QA support for process and cleaning validation activities
* Review and approve validation documentation (protocols, reports, risk assessments)
* Support New Product Introductions (NPI) and tech transfer activities
* Contribute to Continued Process Verification (CPV) and lifecycle validation
* Ensure compliance with GMP and Annex 15 requirements
* Support audit and inspection readiness activities
* Review and oversee cleaning validation strategies and documentation
* Perform and assess MACO calculations
* Participate in cleaning quality reviews and monitoring activities
⚙️ Key Requirements
* Minimum 3–5 years of QA experience in a GMP environment
* Strong knowledge of Annex 15
* Solid understanding of organic chemistry
* Proven experience in process validation:
* New Product Introduction / Tech Transfer
* CPV / lifecycle validation
* Audit support
* Proven experience in cleaning validation:
* Cleaning validation strategy
* Validation master plans, protocols, and reports
* Cleaning monitoring & quality reviews
* MACO calculations
* Strong document review and approval skills with high attention to detail
* DUTCH Language is a necessity
👤 Candidate Profile
* Quality-driven with a strong GMP mindset
* Detail-oriented and structured
* Able to work independently and cross-functionally
* Strong communication skills
🌟 Why Join?
* Work in a highly regulated pharmaceutical environment
* Contribute to critical validation and quality activities
* Be part of a dynamic and collaborative team
* Opportunity to work on NPI and lifecycle validation projects
📩 Interested? Apply directly or reach out for more information.
We welcome applications from all qualified candidates and do not discriminate based on age, gender, or any protected characteristic. Due to high application volume, responses may be limited.