Job Type: Contract
Job ID: JO-2301-31582
Consultant: Karen McHugh
Are you a CQV Site Manager with 15+ years of experience in commissioning and qualification activities for pharmaceutical facilities?
If you have the relevant experience, send your CV to email@example.com or call Karen on +353 17978720 for a confidential chat.
CQV Site Manager - BioPharma - Cork
Our Client is one of Ireland's leading EPCm consultancies and a global player in the Semiconductor, Pharma and Biotech sectors.
CQV Site Manager for Greenfield Biopharma Facility
The C&Q Site Manager shall be responsible for the management of a multi-discipline team carrying out CQ project lifecycle related activities for a biotech facility from Design through to End User Handover
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).
Degree or equivalent in an engineering related discipline
15+ years of experience in commissioning and qualification activities for biotech 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
Single Use Technology Experience
Minimum 12-month contract
Pay rate €100 per hour - €125 per hour
Karen McHugh is the consultant managing this position.
If you are a CQV Specialist interested in roles based in Cork, you can contact Karen by e-mail at firstname.lastname@example.org or phone +353-1-7978720 for a confidential chat.
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