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CQV Lead

Job Description

Overview

We now wish to recruit a CQV Lead for a Pharma Client in Cork to support doc prep and execution.


Responsibilities

  • The lead is required to develop system receipt verification forms and installation verification protocols in support of the CQ effort
  • Provide technical oversight and program management as needed to assure technical work quality and progress of scope
  • Escalate issues that are not promptly resolved including delayed approval of documents, and guidelines
  • Train staff as required to support commissioning
  • Work collaboratively with project support groups (e.g. automation, construction, engineering, end user) and their management and opinion leaders to influence decisions
  • Perform data integrity checks of the engineering design database to support RV/IV generation and resolve any discrepancies
  • Execute RV and IV test cases as directed by the CQ Manager
  • Review C&Q test cases as directed by the CQ Manager
  • Manage and report on their workload and progress weekly to the CQ Manager.
  • Coordinate with and assist other CQ leadership as needed to facilitate completion of CQ work
  • Abide by all safety requirements and procedures pertaining to their role; serve as a positive model to others in this regard

Qualifications

  • BS Engineering or Science (or equivalent experience)
  • 5 years project experience in a CQ, Validation or Quality Role
  • Previous Small Molecule experience in RV, IV and IQ generation and execution an advantage
  • Demonstrated leadership and people management skills
  • Knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification
  • Good written and verbal communication skills with both technical and non-technical