Quality Validation Specialist
Shire is today the global leader in rare diseases.To face our development at our plant of Lessines, we are looking for Quality Validation Engineers
The Quality Validation Engineer is responsible to support quality review of equipment, cleaning, and process or automation system validation at the Lessines facility. The position may focus on Bulk Manufacturing, Finishing and Packing.
- Review/approval of validation documentation, specification documents (URS, Functional/ Design Specification) and study protocols/ reports (IQ/ OQ/ PQ/ PPQ) to ensure compliance to procedures and regulatory requirements.
- Review and approve test incident occurred during the validation in a quality perspective
- Participate and approve the risk analysis linked to validation activities in a quality perspective.
- Review/approval of periodic review of critical system to ensure compliance to procedures and regulatory requirements.
- Collaboration and participations in projects as Quality Representative for Validation. Provide quality guidance for the development of the validation approach. Assure requirements traceability throughout the whole project validation file (from URS to PQ).
- Take part in internal and external audits.
- Master Degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline Minimum 2 to 3 years of relevant industrial experience.
- Critical thinking and problem solving
- Uncompromising dedication to quality
- Able to work in a multi-disciplinary team environment.
- Good level of written/ spoken English is a must (spoken English is a plus).
- Knowledge in Validation/Quality Systems (especially in automatized system is a plus).
- Familiar with Quality Management and GxP Regulations.