**Commissioning, Qualification & Validation Lead Role Overview**
Our client is seeking an experienced Commissioning, Qualification and Validation lead to support their GMP manufacturing facility in Cork.
* The ideal candidate will provide technical leadership and oversight for CQV activities ensuring all systems utilities and equipment are commissioned qualified in line with project timelines industry standards regulatory requirements.
Key Responsibilities
1. Lead the planning coordination execution of CQV activities across assigned systems and equipment.
2. Develop review CQV deliverables including protocols IQ/OQ/PQ test scripts summary reports.
3. Ensure compliance with GMP FDA EMA ICH guidelines throughout qualification validation phases.
4. Oversee contractor vendor related to CQV execution manage deviations change controls CAPAs arising from CQV execution interface project engineering quality manufacturing automation teams drive progress support regulatory inspections audits providing expertise documentation required ensure project milestones met scope schedule budget mentor junior engineers give guidance qualifications
classified as Engineering Science or related discipline Bachelor's degree minimum requirement. A strong understanding of current regulations technologies standards along with good communication problem-solving organizational skills essential for success role requires experience managing cross-functional teams external vendors/contractors.
classified this job highly rewarding due nature variety work environment supported team collaboration present learn opportunities contribute expertize which fostered satisfaction career growth driven pursuit continuous learning we can be better today come join us explore great possibilitiesWe look forward seeing your application send CV via link provided below">',