Overview
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 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.
Qualifications
* Delta V experience desirable for execution phase.
#J-18808-Ljbffr