Website Asset Recruitment

Asset Recruitment

Ref 00954

CQV Project Manager

Responsibilities:
 CQV Subject Matter Expert, , preferably with experience of FDA and EMA requirements
 Directs all CQV Activities on Site
 In consultation with key stakeholders develop CQV Strategy for the project.
 The CQV Project Manager reports to the Project Director and is accountable to coordinate CQV resources, deliverables and activities including validation approach definition, design reviews, turn-over systems definition.
 Manage team of C&Q Engineers on high profile client site throughout the project lifecycle.
 Strong experience with 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) experience
 Identify the appropriate Commissioning and Qualification strategy to apply on specific project and define the list of activities required
 Review and follow-up technical documentation from the early design phase in order to ensure alignment with GMP and CQV requirements
 Investigate and resolve technical issues with assistance from engineers and/or vendors.
 Ensure site project execution is undertaken in compliance with company guidelines, department procedures and safety standards.
 Be familiar with the Mechanical Completion procedure and Construction scope of work (Walkdown, system acceptance, punch list and follow up)
 Schedule preparation and progress review
 Organize and review daily activities of other CQV Engineers assigned to the project
 Project management principles to coordinate CQV activities and reporting to Main Client Representatives and Project Director
 Contractors and Vendors management and coordination
 Final Handover reports to the Client users

Requirements
 Degree or equivalent in an engineering related discipline
 10+ years of experience in commissioning and qualification activities for pharmaceutical facilities
 Strong leadership and team player ability, liaising directly with client and other project key functions
 Knowledge of FDA and EMA requirements for CQV

Experience

 Previous experience as manager/leader of C&Q team
 Strong knowledge of ISPE and ASTM E2500
 Proven experience with international pharmaceutical projects
 Mentor for junior staff members

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