Ref. 01315
CQV Area Lead – API Reactor Process
Asset Recruitment is currently seeking a CQV Area Lead on behalf of our client, a world-class EPCM company, to join their team on a Pharmaceutical project.
Reporting to the department manager / site commissioning manager, the CQV Area Lead is accountable to coordinate CQV resources, deliverables and activities from the validation approach definition, design review, turnover systems definition and C&Q activities at site. Delta V experience desirable for execution phase.
This is an initial 14-month contract position, full-time onsite based in in Co. Tipperary.
Responsibilities
Manage team of C&Q Engineers on high profile client site throughout the project lifecycle.
Develop Validation Master Plan, Commissioning Master Plan, project procedures and commissioning and qualification protocols (SAT/Commissioning, IQ and OQ)
Design Review (DR) process and GMP Risk Assessment (FMEA)
Identify the appropriate Commissioning and Qualification strategy to apply on specific project and define the list of activities required
Be familiar with the Mechanical Completion procedure and Construction scope of work (Walkdown, system acceptance, punch list and follow up)
Audit and follow-up technical documentation from the early design phase in order to ensure alignment with GMP and CQV requirements
Project management principles to coordinate CQV activities and reporting to the company and Client’s PM
Contractors and Vendors management and coordination
Final Handover reports to the Client users.
#J-18808-Ljbffr