CK Group are recruiting for a Commissioning & Qualification Lead to join a biopharmaceutical company at their site based in Carlow on a on a contract basis for 8 months.
Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. They have an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
This Commissioning & Qualification Lead role will be based at our clients manufacturing site in County Carlow.
Up to €57.15 per hour depending upon experience.
Commissioning & Qualification Lead Role:
Support all suite teams during a commissioning and qualification program.
Assist the C&Q Technical Lead in the planning and tracking of activities.
Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation.
Participate in C&Q deliverables (System Impact Assessment, Critical Component Impact Assessments, System Boundary Drawings, Requirement Traceability Matrix).
Manage generation and execution of C&Q documentation (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates & design documentation.
Experience in C&Q as a C&Q Lead/Project Manager on a major capital project.
Working knowledge of process control systems and automation. DeltaV, syringe & vial line experience beneficial.
Knowledge of C&Q documentation required for cGMP process equipment.
Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.
Knowledgeable with latest industry standards and guidelines on C&Q, including ISPE/ASTM.
For more information or to apply for this Commissioning & Qualification Lead position, please contact CK Group, quoting job ref 48213.
It is essential that applicants hold entitlement to work in Ireland