CQV Site Manager

CQV API Project Lead

The 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.

Responsibilities

• Oversight and implementation of the client C&Q Program, ensuring a quality delivery
• Ensure 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 lifecycle
• Summary Report writing/ metrics (status/forecasting)
• Provide leadership to the C&Q team and on-site development of team members in delivery approach
• Forecast needs from various stakeholders and ensure timely intervention to meet schedule
• Generate 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 phases

The C&Q Site Manager reports to

The 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 Competencies

• 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 ability, 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

EEO Statement

We 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.