Looking for candidates with 5 years + C&Q experience, ideally within fill finish
• Primarily lead all C&Q efforts relating to Utilities and Equipment.
• Support QRAES (Quality Risk Assessments) for all related Systems.
• Generate all Test Matrices for related Systems, ensure TM’s include all testing requirements and are approved and under revision control.
• Review and approval of all Vendor Documentation
• Lead for all Factory Acceptance Testing
• Prepare C&QSR’s (Commissioning Summary Reports) for executed documentation
• Ensure all the requirements for the C&Q summary reports are available
• Review all vendor and site change controls for impact to the completed testing as required.
• Liaise with QA in close-out of all C&Q deviations and exceptions.
Candidate's Must have, previous experience commissioning and qualification experience, utilities and process equipment in the pharmaceutical industry. Candidates need to have at least 5 years in a similar role.
HVACs Systems, chilled water and formulation vessel commissioning and qualification experience would make a candidate stand out.
Candidates ideally would have experience from a fill finish company but not strictly necessary
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0)21 2339371