Quality Assurance Specialist
2 weeks ago
Quality Assurance Senior Specialist (Contract – Dundalk, On-site)Pay Rate:€*****/hr – €*****/hrWe are seeking aQA CSQ/CQV Specialist (Contractor/Consultant)to provide oversight of validation activities, ensuring compliance with cGMP, regulatory requirements, and SOPs.This role supports commissioning, qualification, and validation (CQV) activities during facility start-up and transition to commercial operations.Key ResponsibilitiesProvide QA oversight of validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning, processes, storage areas, CTUs, and shipping.Review and approve validation documentation (URS, risk assessments, protocols, reports) to ensure compliance with SOPs and acceptance criteria.Ensure deviations, investigations, and change controls during validation activities are properly managed with QA oversight.Review SOPs related to qualification/validation activities.Support audits, regulatory inspections, and ensure validation readiness.Maintain compliance with EU/FDA cGMP, ISO, and industry standards (GAMP, ISPE, ASME, BPE).Coordinate QA validation activities to meet project timelines.Manage and support QA validation team performance, recruitment, and training.Qualifications & ExperienceB.Sc.or B.Eng.in Science or Engineering (e.g., Biochemistry, Chemistry, Engineering).Experience in QA/Validation in biologics, pharma, or medical device manufacturing (FDA/EU regulated).Strong knowledge of validation requirements in cGMP environments.Familiar with root cause analysis tools (Ishikawa, FMEA, 5 Whys).Strong planning, problem-solving, and critical thinking skills.Ability to work independently in a fast-paced, cross-functional environment.Niche Skills (Preferred/Recommended)CQV Oversight– commissioning & qualification for start-up facilities.Validation Expertise– facilities, utilities, equipment, cleaning, computerized systems.Regulatory Knowledge– EU GMP Annex 15, FDA 21 CFR Part 11, ISO, GAMP 5.Quality Systems– deviations, CAPA, change control, audit readiness.Risk Management Tools– FMEA, Ishikawa, fault tree analysis.Technical Documentation– URS, validation master plans, IQ/OQ/PQ protocols.
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Quality Assurance Specialist
2 weeks ago
Dundalk, Ireland Almac Group Full timeLocation:DundalkHours:37.5 hours per weekSalary:CompetitiveBusiness Unit: Pharma ServicesOpen To: Internal & External ApplicantsRef No.:HRJOB*****?The RoleThe Quality Assurance Specialist will play a crucial role in assessing and enhancing the Quality System to ensure Good Manufacturing Practice (GMP) compliance and the quality of pharmaceutical...
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Quality Assurance Senior Specialist
2 weeks ago
Dundalk, Ireland Kpc International Full timeQuality Assurance Senior Specialist Dundalk Co LouthQA CSV-CQV specialist contractor/Consultant, reporting to the QA CSQ/CQV Lead.This role is responsible for oversight of all validation activities ensuring compliance with current regulatory requirements, cGMP and company SOPs.It includes validation/qualification activities for facilities, utilities,...
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Senior Quality Assurance Specialist
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Dundalk, Ireland Orion Group Full timeOrion Group Life Sciences are currently recruiting aQuality Assurance Senior Specialiston behalf of our Multinational Biopharmaceutical Client based in Dundalk on an initial 11-Month contract with potential to extend.QA CSQ/CQV specialist contractor/Consultant, they will be reporting to the QA CSQ/CQV Lead.This role is responsible for oversight of all...
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Quality Assurance Specialist
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Dundalk, Ireland Claran Consultants Ltd Full timeQuality Assurance Specialist QA CSQ/CQV specialist responsible for oversight of all validation activities ensuring compliance with current regulatory requirements, cGMP and company SOPs. It includes validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning, processes, storage areas, controlled temperature units...
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Quality Assurance Cqv
2 weeks ago
Dundalk, Ireland Lsc, Life Science Consultants Full timeLSC have a great contract opportunity for Quality Assurance CQV to join a leading Biopharmaceutical Facility in Louth.**If you have 5 years of experience and are ready for your next challenge, this could be the perfect project for youABOUT THE PROJECT - KEY RESPONSIBILITIES:**Ensure the quality oversight of the qualification/validation activities of all...
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Senior Qa Validation Specialist
2 weeks ago
Dundalk, Ireland Psc Biotech® Corporation Full timeWe are currently hiring a Senior QA Validation Specialist for our Dundalk sitean exciting opportunity to grow your career with a leading Biotech consultancy.The Quality team have a great opportunity for a Quality Assurance Senior Specialist at our Dundalk facility.QA CSQ/CQV specialist contractor/Consultant, he will be reporting to the QA CSQ/CQV Lead.This...
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Qa Cqv Specialist
2 weeks ago
Dundalk, Ireland Pe Global Full timePE Global are currently recruiting for a Quality Assurance Senior Specialist, for a client site in Dundalk.11 month initial contractQA CSQ/CQV specialist contractor/Consultant, will be reporting to the QA CSQ/CQV Lead.This role is responsible for oversight of all validation activities ensuring compliance with current regulatory requirements, cGMP and company...
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Senior Validation Specialist
2 weeks ago
Dundalk, Ireland Psc Biotech® Corporation Full timeAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in ****, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide.We provide cloud-based software solutions for Quality Management and Regulatory Inspections,...
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Engineering Support Specialist
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Dundalk, Ireland Psc Biotech® Corporation Full timeAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in ****, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide.We provide cloud-based software solutions for Quality Management and Regulatory Inspections,...
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Qa Cqv Specialist
2 weeks ago
Dundalk, Ireland Psc Biotech® Corporation Full timeAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in ****, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide.We provide cloud-based software solutions for Quality Management and Regulatory Inspections,...
