Website Asset Recruitment
The CQV Site Manager reports to the Site Project Manager and CQV Department Manager and is accountable in coordinating CQV resources, deliverables and activities from validation approach definition, design review, turn-over systems definition till C&Q activities at site.
• Oversight and implementation of the client CQ Program, ensuring a quality delivery
• Adherence to CQ plans for process equipment and labs scope and input to scheduling activities
• Planning, scheduling, and management of FAT attendance
• Training of team members in delivery approach including KNEAT
• Overview of protocol development and execution activities for Design review, Installation Verification and
Operational Verification aspects.
• Technical oversight and guidance to the CQ team.
• Safety oversight of the CQ team, in collaboration with the project safety team.
• Oversight of Change Management activities during project lifecycle
• Summary Report writing/ metrics / schedule reviews
• Provide leadership to the C&Q teams on site
• Forecast needs from various stakeholders and ensure timely intervention to meet schedule
• Driving project on schedule
• Interfacing with Client representatives on project team, Engineering Team, Quality team and End Users
during the different project phases.
• 15+ years of experience in CQV activities for biotech pharmaceutical facilities
• Strong leadership and team player ability, liaising directly with client and other project key functions
• Degree or equivalent in an engineering related discipline
• Previous experience as manager/leader of C&Q team
• Strong knowledge of ISPE and ASTM E2500