Job Title: C&Q Leader Services
We are seeking an experienced Commissioning, Qualification & Validation (CQV) professional to lead CQV activities at a GMP manufacturing facility in Cork.
Job Description
1. Lead the planning, coordination and execution of CQV activities across assigned systems and equipment.
2. Develop and review CQV deliverables including protocols IQ/OQ/PQ, test scripts and summary reports.
3. E nsure compliance with cGMP FDA EMA and ICH guidelines throughout all qualification and validation phases.
4. Overs ee contractor/vendor activities related to C Q V execution Mange deviations change controls CAPAs arising from c Q V e x ecution Interface project engineering quality manufacturing automation teams drive project progress Support regulatory inspections audits provide c q v expertise documentation as required Ensure project milestones met within scope schedule budget Mentor junior cq v engineers technical guidance
Qualifications & Experience:
person must have Bachelor's degree Engineering Science or related discipline 8+ years experience Commissioning Qualification Validat ion Pharmaceutical Biopharma industry Proven track record leading cqv activi ties gmp facilitie utilities process equipme nt cleanrooms Strong understand ing regula tory requir ements fda ema cg mp astm e2500 ispe guidelinexperiencemanaging cross-functionalteams extern al vendors/contractors Excellent problem-solving communication organisational skills Ability work independently driving projecdeliverables under tight deadlines
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