CQV Manager

4 weeks ago

Cork, Cork, Ireland Project Delivery Partners Full time

JOB SUMMARY

Reporting to CQV Manager, the CQV Lead role will lead and coordinate the CQV project activities in line withthe site project strategy. The CQV Lead will work cross all project functions including but not limited to process

engineering functionally across Operations, Operational Engineering, Quality Operations, EHS, Logistics, Lean& Digital to understand their functional requirements and develop and execute the optimum validation strategy.

MAIN RESPONSIBILITIES

  • Accountable for the following activities (but not exclusively),
  • Lead and coordinate CQV projects, ensuring timely execution and compliance with industry regulations.
  • Support and coordinate the transition to a digitized C&Q platform
  • Ensure effective resource planning is established and managed throughout the project in line withschedule and associated CQV budget including the management of CQV personnel.
  • Manage and coordinate equipment qualification activities, including but not limited to FactoryAcceptance Testing (FAT), SAT, DQ Installation -Qualification (IQ), Operational Qualification (OQ), andPerformance Qualification (PQ).
  • Develop and maintain project plans, schedules, and budgets to ensure alignment with businessobjectives.
  • Act as the primary point of contact between clients, internal teams, and external vendors to drive projectsuccess.
  • Manage and coordinate all CQV documentation to support CQV activities
  • Identify and mitigate project risks while ensuring project deliverables meet required quality andcompliance standards.
  • Support continuous improvement initiatives by implementing best practices in project execution andquality assurance.
  • Ensure that all stakeholders, including client teams, vendors, and subcontractors, adhere to establishedproject protocols.
  • Provide leadership in team meetings and facilitate problem-solving discussions to ensure projectmilestones are met.
  • Disclaimer: This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirementsor working conditions associated with the job. While this is intended to be an accurate reflection of the currentjob, management reserves the right to revise the job or to require that other or different tasks be performed

EDUCATION/QUALIFICATIONS

  • Experience in the deployment and/or extensive working knowledge/ experience of a digitized C&Qplatform i.e. Kneat Solutions
  • Clear understanding and previous experience in deployment and execution of a RBV (Risk BasedValidation) process in line with the ISPE guidelines.
  • Experience of managing teams or projects in a fast paced and complex environment.
  • Relevant qualification (Degree) and / or relevant experience of 10 + years in biotech / pharmaceuticalindustry qualifying GXP systems.
  • Significant project lifecycle experience in delivering CQV projects for Capex projects.
  • Clear understanding of regulatory requirements for EU and other regulatory bodies ensuring CQV isdelivered meeting all regulatory requirements and guidelines.
  • Excellent verbal and written communication skills, Experience in developing a strong workingrelationship with other departments.
  • Strong analytical problem-solving skills. Dynamic decision maker, effective planner, andcommunicator
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