Job Title: Quality Assurance Specialist-Validation
In this role, you will be responsible for ensuring that processes, equipment, and facilities in our biologics manufacturing facility meet the highest GMP and regulatory standards.
About the Role:
* You will serve as the QA expert for validation activities, guiding strategies, resolving issues, and ensuring compliance.
* Review and approve validation documents for facilities, equipment, and utilities.
* Manage Quality Management System (QMS) areas like deviations, change controls, CAPAs, audits, and vendor management.
* Collaborate with cross-functional teams to support new product introductions and continuous improvements.
* Apply risk assessment tools (like FMEA) to ensure robust processes.
* Maintain projects on track by meeting timelines for GMP and validation reviews.
Requirements:
* A degree in science or engineering.
* 5+ years' experience in a GMP quality role with a strong focus on validation.
* Solid understanding of validation processes, project life cycles, and cGMP regulations.
* A proactive, problem-solving mindset and strong teamwork skills.
What We Offer:
* A competitive salary: €65,000 - €80,000 per year.
* A cutting-edge work environment with opportunities for growth and development.
* A comprehensive benefits package.
* The opportunity to make a real impact in the field of biologics manufacturing.