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Senior CQV Project Coordinator

2 weeks ago

Cork, Cork, Ireland beBeeCqv Full time €90,000 - €120,000

CQV Manager Job Overview

We are seeking a highly experienced CQV Lead to lead and coordinate the CQV project activities in line with the site project strategy, working cross-functionally across Operations, Operational Engineering, Quality Operations, EHS, Logistics, Lean & Digital.

Main Responsibilities:

  • 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, including the management of CQV personnel.
  • Manage and coordinate equipment qualification activities, including Factory Acceptance Testing (FAT), SAT, DQ Installation -Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Develop and maintain project plans, schedules, and budgets to ensure alignment with business objectives.
  • Act as the primary point of contact between clients, internal teams, and external vendors to drive project success.
  • Manage and coordinate all CQV documentation to support CQV activities.
  • Identify and mitigate project risks while ensuring project deliverables meet required quality and compliance standards.
  • Support continuous improvement initiatives by implementing best practices in project execution and quality assurance.
  • Ensure that all stakeholders adhere to established project protocols.
  • Provide leadership in team meetings and facilitate problem-solving discussions to ensure project milestones are met.

Requirements:

  • Experience in deployment and/or extensive working knowledge/experience of a digitized C&Q platform i.e. Kneat Solutions.
  • Clear understanding and previous experience in deployment and execution of a RBV (Risk Based Validation) 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/pharmaceutical industry 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 is delivered meeting all regulatory requirements and guidelines.
  • Excellent verbal and written communication skills, experience in developing a strong working relationship with other departments.
  • Strong analytical problem-solving skills.
  • Dynamic decision maker, effective planner, and communicator.