CQV API Project LeadThe C&Q Site Manager shall be responsible for the management of a multi-discipline team carrying out CQ project lifecycle related activities for an API facility from Design through to End User Handover.ResponsibilitiesOversight and implementation of the client C&Q Program, ensuring a quality deliveryEnsure that process equipment qualification activities are completed 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 lifecycleSummary Report writing/ metrics (status/forecasting)Provide leadership to the C&Q team and on-site development of team members in delivery approachForecast needs from various stakeholders and ensure timely intervention to meet scheduleGenerate and maintain C&Q schedules to plan and track activities over the C&Q life‑cycle.Interfacing with Client representatives on project team, Engineering Team, Quality team and End Users during the different project phasesThe C&Q Site Manager reports toThe Site Project Manager and C&Q Project Manager and is accountable to coordinate C&Q resources, deliverables and activities from the qualification approach definition, design qualification, turn-over systems definition till C&Q activities at site (IOQ complete).Qualifications Key CompetenciesDegree or equivalent in an engineering related discipline15 years of experience in commissioning and qualification activities for API pharmaceutical facilitiesStrong leadership and team player ability, liaising directly with client and other project key functionsPrevious experience as manager/leader of C&Q teamStrong knowledge of ISPE and ASTM E2500Strong knowledge in KNEAT and Delta VEEO StatementWe welcome applications from every walk of life and are committed to diversity within the industries we support, as a certified Inclusive Recruiter and Armed Forces friendly employer.
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