▷ Apply in 3 Minutes: QA Specialist
2 weeks ago
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 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, equipment, computerized systems, cleaning, processes, storage areas, controlled temperature units (CTUs), and shipping. An important aspect of this role is provision of QA oversight to the Commissioning, Qualification and Validation (CQV) activities associated with the Dundalk Facility start-up project and supporting the transition from project phase through to sustaining phase with respect to validation activities. Responsibilities Ensure the quality oversight of the qualification/validation activities of all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs), and shipping processes. Ensure that all validation documentation and associated data, including but not limited to; plans, URSs, quality risk assessments, protocols, and reports, are reviewed and approved by QA for conformance to SOPs, specifications, and other applicable acceptance criteria. Ensure that all events/deviations, investigations, and change evaluations that occur during qualification/validation activities have appropriate QA oversight, QA review and approval and adhere to SOPs and cGMP requirements. Review SOPs relating to qualification/validation activities. Provision of support in Regulatory inspections and Client audits. Provision of QA Validations expertise to maintain validation status of the facility. Maintain an understanding of cGMP regulations and guidance in relation to all aspects of validation and/or qualification of facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs), and shipping processes. Coordinate all QA Validations activities to ensure schedule adherence and on time delivery of project deliverables. Manage and develop the QA Validations team including, but not limited to, activities such as performance management, recruitment, and training. Other quality activities as needed and assigned. Special knowledge Deep knowledge of GxP regulations applicable to biologics manufacturing (e.g. EU-GMP, FDA, ISO) and the industry standards applicable to validation, including but not limited to; GAMP, ISPE, ISO, ASME and BPE. Knowledge of trouble shooting and problem-solving skills. Knowledge of formal root cause analysis methods and tools such as Ishikawa diagrams, FMEA etc. Skills Independent and self-motivated. Able to multi-task in fast-paced, dynamic working environment. Strong planning, organisational, and time management skills. Critical thinking skills. Able to operate across functional boundaries, both internal and external. Education background/ Experience B.Sc. or B. Eng in a Scientific or Engineering related discipline (e.g. biochemistry, chemistry, engineering). Experience in a Quality Engineering/Quality Assurance/Quality Validations role for Biologics or related pharmaceutical/ medical device manufacturing in a FDA/ EU regulated environment. Thorough understanding of the validation requirements associated with a cGMP manufacturing facility. Strong technical aptitude is required. Skills: CQV CSQ Validation GxP cGMP
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Qa Specialist
2 weeks ago
Dundalk, Ireland Claran Consultants Ltd Full timeThe 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 role is responsible for oversight of all validation activities ensuring compliance with current regulatory requirements, cGMP, and company SOPs.It includes...
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QA Engineer
2 days ago
Dundalk, Ireland Reperio Human Capital Full timeQA Engineer 173076 Desired skills: QA, Test, Automation, ERP Hybrid (Dundalk) or Remote (Ireland/UK)Reperio has partnered with a growing software company that’s looking for a skilled QA Software Tester. This is a full-time permanent role offering hybrid working (3 days a week on-site in Dundalk) or the option to work fully remote from anywhere in Ireland...
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▷ Apply in 3 Minutes! Project Manager
1 week ago
Dundalk, Ireland Stott and May Full timeOverview Job Tittle: Project Manager Location: UK Based (Remote or Hybrid TBC) Type: Permanent, Full-time Salary: Competitive Our leading software client is growing and looking for a skilled Project Manager to join their team. This is an exciting opportunity to take the lead on high-impact projects that help thousands of businesses worldwide run smarter...
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Deputy Manager New
3 weeks ago
Dundalk, Ireland CPL Full timeCPL Healthcare is excited to announce we have partnered up with a client who provides therapeutic care and support to children and young people in a nurturing home environment while providing safe spaces for children to flourish and reach their full potential. We are currently accepting CVs from experienced Social Care Professionals who wish to work as a...
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Dundalk, Ireland FlexiStaff Full timeProcurement & Office Co-ordinator - Kitchen Industry Location: Drogheda Salary: €40,000 - €45,000 per annum Hours: Monday to Friday, Full-time About the Role We are seeking an organised and detail-oriented Procurement & Office Co-ordinator with strong knowledge of the kitchen industry to join our team. This role will involve managing purchase orders,...
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Qa Lead Drug Substance Manufacturing
4 weeks ago
Dundalk, Louth, Ireland Wuxi Biologics Ireland Limited Full timeCompany description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries.Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.The...
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[10/3/2025 A] Facilities Specialist
1 week ago
Dundalk, Ireland WuXi Biologics Ireland Limited Full timeCompany description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The...
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Qa Lead Drug Substance Manufacturing
3 weeks ago
Dundalk, Ireland Wuxi Biologics Ireland Limited Full timeCompany description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries.Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.The...
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▷ Urgent! QA Lead Drug Substance Manufacturing
3 weeks ago
Dundalk, Ireland WuXi Biologics Ireland Limited Full timeCompany description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The...
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Dundalk, Louth, Ireland Brightwater Full timeAssociate Director Quality Assurance, Drug Substance & Drug Product About the Company Join an innovative biopharmaceutical company at the forefront of vaccine development. This growing site is building a dynamic team, focused on operational excellence, compliance, and cutting-edge technology in a fast-paced, startup-like the Position We are seeking an...
