Website Asset Recruitment
CQV Project Manager
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
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
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