Website Asset Recruitment

Asset Recruitment

Ref. 1376

CQV API Project Lead

The CQV API Project Lead will be responsible for the management of a multi-discipline team carrying out C&Q project lifecycle related activities for an API facility from Design through to End User Handover.

Reporting to the Site Project Manager and to the C&Q Project Manager, the successful candidate will be 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).

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

Requirements:

• 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

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