Beschreibung

In this role, you will take charge of the CQV strategy for a cutting-edge manufacturing site, managing qualification projects and ensuring compliance with the highest quality standards. Your expertise will shape the facility's operations while maintaining equipment qualifications and representing the department during audits.

Anforderungen

• •Master's/Bachelor's degree in mechanical engineering, pharmaceutical technology, medical technology, chemistry, process engineering, or similar
• •Sound knowledge and several years of experience in plant qualification in a GMP surrounding
• •Good understanding of GMP, technical and bioprocess understanding, quality and safety awareness
• •Proactive collaboration with Customer Delivery, QA, and IT Circles

Aufgaben

• •Lead the CQV strategy for the new manufacturing site
• •Independently plan and manage qualification projects
• •Engage specialized external companies for qualifications
• •Supervise and check assignments from external companies
• •Conduct qualifications during DQ, IQ, OQ, and PQ phases
• •Support FATs and SATs
• •Maintain the qualified condition of equipment
• •Plan and implement necessary requalifications
• •Perform periodic reviews of qualifications
• •Develop the qualification concept with updated standards and guidelines
• •Represent the department during audits and inspections

Benefits