Job Title: Quality Assurance Specialist-Validation
You will be responsible for ensuring processes, equipment, and facilities meet the highest GMP and regulatory standards in a biologics manufacturing company.
Responsibilities:
* Be 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.
* Keep 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.
Benefits:
* Competitive salary: €60,000 - €80,000 per annum.
* Benefits package including hybrid work opportunities.
* Possible career advancement opportunities in a cutting-edge facility.
About the Role:
This is an opportunity to make a meaningful impact in a team that's shaping the future of manufacturing. You will have the chance to apply your expertise and ideas to drive success.