Quality Control Microbiologist
2 weeks ago
Role:QC MicrobiologistLocation:Fully on site in Dundalk, IrelandContract:Until June **** (with possibility of extension)- Full-time, 39 hours weeklyCompany:A Global Pharmaceutical CompanyRole Overview:Reporting to the Microbiology Lead, this role provides real-time QC oversight for Drug Substance/Drug Product manufacturing.It is a key position within Quality, directly supporting daily manufacturing activities to ensure compliance with cGMP and corporate/local SOPs.Key responsibilitiesProvide QC support for technology transfer and commercial manufacturing operations.Review SOPs, risk assessments, change controls, and related documentation for DS/DP operations.Lead/participate in microbiology projects: microbial method validation and testing, environmental monitoring, organism identification, facility qualification, cleaning validation, and process validation.Perform microbial testing; support atypical/OOS investigations; drive/track change controls and CAPAs.Monitor and trend method performance with supervisors and cross-functional partners.Author technical documents: methods, protocols, validation/qualification plans and reports, SOPs.Offer technical guidance and assess/introduce new microbiology technologies.Support the Microbiology Lead in developing microbial control strategies, quality enhancements, and operational efficiency improvements.Communicate effectively and take a lead role in project management interactions with internal and external stakeholders (e.g., Quality Assurance, Regulatory Affairs, Analytical Development, clients).Serve as a primary point of contact for project coordination, including emails and client meetings.Prepare for and participate in regulatory inspections (e.g., FDA, EMA) and client/internal cGMP audits.Perform all tasks in compliance with applicable regulations, international standards, and company policies and SOPs.Other duties as assigned.EducationBSc in Microbiology or a related discipline.1–3 years of relevant industry experience.Work experienceExperience in a highly regulated environment.Ability to interpret technical documentation.Working knowledge of cGxP requirements and regulations.Practical problem-solving skills, including formal root-cause tools (e.g., Ishikawa, FMEA).Professional knowledgeMicrobiological testing and peer review.GMP compliance and inspection readiness.
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Quality Control Microbiologist
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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Quality Control Microbiologist
2 weeks ago
Dundalk, Ireland Pe Global Full timeThe role:PE Global is currently recruiting for a QC Microbiology Analyst on behalf of a leading pharmaceutical company based in Dundalk..This is an initial 11-month contract role.Shift :Please note this role will start on days to get trained up and move to shift 7-7 days only.4 on 4 off.Shift Pattern: For days it will be Monday – Friday.For shift the...
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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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Quality Assurance Specialist
2 weeks ago
Dundalk, Ireland Independent Solutions Full timeQuality 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...
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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 Quality Assurance Specialist
2 weeks ago
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
1 week ago
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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Administrative Assistant
2 weeks ago
Dundalk, Ireland Aphex Full timePurposeReporting to the Engineering Centre of Excellence Lead, the Engineering Support Specialist plays a critical role in ensuring the smooth and efficient operation of the Engineering department.This position provides comprehensive administrative and coordination support, facilitating effective communication, documentation control, and training management...
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Engineering Support 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,...
