Job Ref: 2897 Recruiter: Tom Doyle
Country: Ireland Location: Cork
Job Category: Construction, Process, Pharma Life Science, Salary Range: €Negotiable

Job Description

CQ RV/ IV Lead (Cork)

Suitable candidates will have:

BS Engineering or Science (or equivalent experience) a minimum of 4 years project experience in a CQ, Validation or Quality Role.

Knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification.

Demonstrated leadership and people management skills.  Excellent written and verbal communication skills with technical and non-technical staff.

It would be advantageous if Candidates have Small Molecule experience in RV, IV and IQ generation and execution.

Role Responsibilities

  • The RV/IV 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 RV/IV scope.
  • Escalate issues that are not promptly resolved including delayed approval of RV/IV 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.

Contact: Tom Doyle at kppm in strictest confidence: Ph: 086 8205038


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