- Our client is looking for a CQV (Commissioning, Qualification, and Validation) Engineer to join their busy pharmaceutical site in Co. Waterford.
- The CQV Engineer will be working as part of the client’s Data Integrity Programme.
- This position is an ongoing contracting opportunity.
Core Duties and Responsibilities:
- Documenting User Access Matrix (UAM) for Critical Systems
- Developing Data Flow Diagrams (DFD) as a deliverable of Data Integrity Maturity Model (DIMM)
- Analysing Audit Trail Reviews (ATR) as a deliverable of Data Integrity Maturity Model (DIMM)
- Documenting Audit Trail Review requirements (ATR) as a deliverable of Data Integrity Maturity Model (DIMM)
- Supporting Data Integrity Risk Assessments (DIRA)
- Alignment with Compliance teams on requirements for Audit Trail Review (ATR) on Critical Systems
- Supporting Project Team in delivering the requirements of the Data Integrity Maturity Model (DIMM) program
- Working with QC / Manufacturing personnel to document above requirements
Minimum Qualifications and Experience:
- Degree qualified in relevant engineering/technical discipline required.
- Experience with DI / CSV / Validation required.
- Relevant experience in a pharmaceutical environment preferred.
- Excellent communication skills (interpersonal, presentation & writing).
- Ability to effectively communicate technical & non-technical information.
- Works well with others at all levels of the organization, across multi-sites, and in a multi-national environment.
- Initiative – able to work in a self-directed manner to see issues through to completion.
- Highly motivated and has the ability to multi-task.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland.
+353 21 2066178
Please note, we do not require agency assistance with this role.