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
or email tom@kppm.ie
To view our privacy policy Click here
Apply for this job
