CQV Site Manager

Ref. 1376

CQV API Project Lead

Our client is a leading global EPCM company with worldwide operations and projects across Ireland. They are currently seeking an experienced CQV Site Manager to join their team in an exciting project located in Co. Tipperary. The CQV Site Manager will manage a multi-disciplinary team responsible for delivering C&Q lifecycle activities for an API manufacturing facility, from detailed design phase through to final end-user handover.

Reporting to both the Site Project Manager and to the C&Q Project Manager, the successful candidate will be accountable for coordinating C&Q resources, deliverables and activities across the full lifecycle – from qualification approach definition, design qualification, turn-over systems definition till C&Q activities at site (IOQ complete).

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• Oversight and implementation of the client C&Q Program, ensuring high-quality delivery
  
• Ensure that process equipment qualification activities are carried out in line with Site procedures, cGMP and best practices
  
• Overview of protocol development and execution activities for the Commissioning & Qualification aspects
  
• Planning, scheduling, and coordination of vendors (FAT, SAT& IOQs)
  
• Provide technical oversight and guidance to the C&Q team
  
• Safety oversight of the C&Q team, in collaboration with the project safety team
  
• Oversight of Change Management activities during project lifecycle
  
• Summary Report writing/ metrics (status/forecasting)
  
• Antecipate needs from various stakeholders and ensure timely intervention to meet schedule
  
• Develop and maintain C&Q schedules to plan and track activities over the C&Q life cycle
  
• Provide leadership to the C&Q team and on-site development of team members in delivery approach
  
• Interfacing with xcfaprz Client representatives on project team, Engineering Team, Quality team and End Users during the different project phases
  

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• Degree or equivalent in an engineering related discipline
  
• 15+years of experience in commissioning and qualification activities for API pharmaceutical facilities
  
• Strong leadership and team player skills, liaising directly with client and other project key functions
  
• Previous experience as manager/leader of C&Q team
  
• Strong knowledge of ISPE and ASTM E2500
  
• Strong knowledge in KNEAT and Delta V