For my client – a leading Cell & Gene Therapy CDMO in Geleen, NL – I am looking for a QA Specialist to perform validation activities in a role that will offer up a new challenge in a dynamic and growing team.
Why This Role?
As a QA Specialist in Process, Method & Shipping Validation, you'll be at the forefront of cutting-edge validation processes that ensure product excellence from the lab to the market. You’ll collaborate with cross-functional teams, contributing to innovative projects that shape the future of pharmaceuticals while safeguarding product integrity, patient safety, and regulatory compliance.
What You'll Do
Lead and oversee process and method validation, ensuring compliance, safety, and efficiency across manufacturing, cleaning, disinfection, and shipping protocols.
Be the key authority on process performance qualification (PPQ) plans, risk assessments, and FMEA, ensuring seamless alignment with global regulatory standards.
Manage the end-to-end process validation lifecycle, from initial strategy through to continuous process verification (CPV).
Provide expert validation knowledge, supporting key projects and acting as a trusted quality advisor.
Ensure proper documentation of deviations, corrective actions, and systemic solutions to maintain process excellence.
Facilitate the correct application of validation requirements for disinfectant efficacy and support cross-functional teams in implementing best practices.
Key Requirements
Expert knowledge in cGMPs, ICH regulations, FDA guidelines, US and EU pharmacopoeias, and modern validation practices.
A minimum of 3 years’ experience with validation activities within the pharmaceutical industry, especially process, method, and shipping validation.
Experience with method development and a scientific background.
Experience with cell Therapy is an advantage.
Problem-solving skills and a strategic outlook, with the capability to manage validation deviations, CAPA, and change control.
Hands-on experience in validation process oversight, with a commitment to continuous improvement and innovation.
Practicalities
Location: Geleen, The Netherlands
Contract Type: Permanent
Start Date: ASAP
Interested?
We want to hear from you! If you’re excited by this opportunity, send your CV to Khanyi Mabena at k.mabena@panda-int.com or call her on +31 2020 44502.