Quality & Regulatory Affairs Specialist
3 weeks ago
Fantastic opportunity to join a growing genericpharmaceutical organization inCork. TheQuality & Regulatory Specialistwill be responsible for quality systems and quality assurance activities, compliance with cGxPs, supporting the release of finished products and investigations of product-related issues.This role also offers a Hybrid working model. Overview of Main Responsibilities (full job description available on request): Ensures compliance with cGMP's & Environmental, Health & Safety regulations. Ensure compliance & execute all activities to the Quality Management System such as non-conformance investigations; deviations; change control, complaints, document control system, record retention & CAPA Executes the finished product non-conformance process. Supports document reviews to ensure timely release of finished product. Executes all regulatory updates to product labeling to ensure timely & compliant launch of finished products. Manages & executes all routine regulatory updates & submissions of finished product labelling. Creation and maintenance of National Drug Codes (NDC) & Universal Product Codes (UPC) Creation and maintenance of Structured Product Labeling (SPL) for FDA submissions. Ensures the company and product are registered in the appropriate markets & with agencies as required. Reviews and approves product labeling, patient package inserts and other product labeling. Maintain familiarity with current regulatory trends. Performs related duties as assigned. What the ideal candidate looks like: BSc in a scientific discipline Minimum of 5 years in a cGMP facility in a Quality Assurance role. Experience in the Pharmaceutical industry is preferred. What you will get in return: Competitive Salary. Pension. Healthcare. Bonus. For a confidential discussionandmore information on the role,please contactKevin Griffin Kevin Griffin Skills: Quality Regulatory Affairs Quality Assurance
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Regulatory Affairs Manager
1 month ago
Cork, Ireland IE13 Alcon Laboratories Company Full timeRegulatory Affairs Manager At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an...
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Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines...
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Associate Quality Specialist
1 month ago
Cork, Ireland PSC Biotech Full timeAssociate Quality Specialist (Quality Systems) Industry Pharma/Biotech/Clinical Research Work Experience 1-3 years City Cork State/Province Cork Country Ireland Job Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in...
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Sr. Director
4 weeks ago
Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. Lilly offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development...
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Cork, Ireland Eli Lilly and Company Full timeAssociate / Senior Associate - Regulatory CMC page is loaded Associate / Senior Associate - Regulatory CMC Apply locations Ireland, Cork time type Full time posted on Posted 16 Days Ago job requisition id R-64531 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in...
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Sr. Director
1 month ago
Cork, Ireland Eli Lilly and Company Full timeSr. Director - Global Regulatory Scientist – Early Clinical Development page is loaded Sr. Director - Global Regulatory Scientist – Early Clinical Development Apply locations Ireland, Cork time type Full time posted on Posted 4 Days Ago job requisition id R-62024 At Lilly, we unite caring with discovery to make life better for people around the...
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Associate/ Sr. Associate
4 weeks ago
Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. Purpose: The Global Clinical Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery Excellence (RDE), is accountable for the operational and technical registration management processes that support the expedited delivery of safe and...
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Associate Director
1 month ago
Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines...
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Principal Scientist
1 month ago
Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help...
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Associate Director
1 month ago
Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines...
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Associate Specialist
3 weeks ago
Cork, Ireland PSC Biotech Ltd Full timeAbout PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, 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...
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Cork, Ireland Life Science Recruitment Ltd Full timeA German speaking Customer Excellence and Medical Solution Associate or Senior Associate is required to join a leading global Pharmaceutical business based in Cork with Hybrid working. This is a fantastic opportunity to join a diverse and vibrant business that is dedicated to discovering and bringing life-changing medicines to those who need them. The Role...
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Sr. Principal
1 month ago
Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. Organisation Overview: At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and...
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Sr. Principal
1 month ago
Cork, Ireland Eli Lilly and Company Full timeSr. Principal - CMC Pre-Approval Regulatory Scientist page is loaded Sr. Principal - CMC Pre-Approval Regulatory Scientist Apply locations Ireland, Cork time type Full time posted on Posted Today job requisition id R-59145 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader...
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Associate / Senior Associate - Regulatory CMC
3 weeks ago
Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those...
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Associate / Sr Associate - Regulatory Labeling
1 month ago
Cork, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. About Lilly At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines...
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AML QA Specialist
4 weeks ago
Cork, Ireland Amazon Ireland Support Services Limited - A94 Full timeThe AML Programme team in Registration and Compliance (R&C, part of Selling Partner Risk) is looking for a Chinese-speaking quality control specialist to join a team of quality specialists covering the Know Your Customers programme. The role is critical to ensure that Amazon’s payments businesses expand with appropriate controls and quality processes in...
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AML QA Specialist
1 month ago
Cork, Ireland Amazon Ireland Support Services Limited - A94 Full timeThe AML Programme team in Registration and Compliance (R&C, part of Selling Partner Risk) is looking for a Portuguese-speaking quality control specialist to join a team of quality specialists covering the Know Your Customers programme. The role is critical to ensure that Amazon’s payments businesses expand with appropriate controls and quality processes in...
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Documentation Specialist
1 month ago
Cork, Ireland PSC Biotech Ltd Full timeAbout PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, 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...
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MSAT Specialist- Thermal
3 weeks ago
Cork, Cork, Ireland Cpl Full timeKenny-Whelan (a specialist division of the CPL group) are hiring a MSAT specialist -Thermal Validation to work on contract at Janssen Sciences in Ringaskiddy CorkMSAT Specialist – Thermal (12 months) Location: Ringaskiddy, Cork, Ireland Reports to: Manager, Manufacturing Science & Technology Position Summary: We have an exciting opportunity for a MSAT...