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