GMP Compliance Expert
1 week ago
We are looking for a highly experienced Senior Process Engineer to join our team at Fastnet.
The successful candidate will have a strong background in process engineering, with a degree in a relevant field, such as Process, Chemical, Mechanical or equivalent discipline.
They will also have experience in leading engineering initiatives in a GMP/GCP compliant environment, with a minimum of 5-8 years of experience.
Biopharma operations experience and 3+ years of directly related experience in Filling Operations are essential for this role.
The ideal candidate will be responsible for ensuring that process engineering activities are implemented in a compliant manner.
This includes provision of technical engineering support to Drug Product Filling operations, including process performance monitoring, troubleshooting, and process optimisation.
You will also be responsible for fulfilling system ownership responsibilities for assigned Drug Product Filling equipment, including production recipe and cleaning recipe updates where required.
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GMP Readiness Expert
8 hours ago
Cork, Cork, Ireland PM Group Full timeJob SummaryWe are seeking a highly skilled GMP Readiness Expert to join our team at PM Group. The successful candidate will be responsible for supporting the development, execution, and oversight of operational readiness strategy and roadmap for production start-up.In this role, you will work closely with our CQV group to ensure a smooth transition from...
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GMP Compliance Manager
1 week ago
Cork, Cork, Ireland Westbourne It Global Services Full timeJob OverviewWestbourne IT Global Services seeks a highly skilled professional to fill the position of Quality Assurance Lead. The successful candidate will be responsible for providing quality leadership, direction, and governance for the specific area of responsibility.The ideal candidate will have a strong understanding of GMP compliance and experience in...
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GMP Compliance Expert
8 hours ago
Cork, Cork, Ireland PM Group Full timeAbout PM GroupAs a leading provider of outsourced technical services, PM Group partners with global leaders to find the best people for their current and ongoing business needs.We are seeking a skilled QA Validation Specialist to join our Client Validation team. In this role, you will be responsible for reviewing and approving validation lifecycle activities...
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GMP Compliance Specialist
3 days ago
Cork, Cork, Ireland Hovione Full timeAbout the CompanyHovione is a leading provider of Contract Development and Manufacturing services to the pharmaceutical industry. With a strong focus on innovation and quality, we help our customers bring new and off-patent drugs to market. Our team of over 1950 employees from 36 different nationalities, located across Asia, Europe, and North America, works...
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Regulatory Compliance Expert
4 hours ago
Cork, Cork, Ireland TN Ireland Full timeJob Description:We are seeking a highly skilled Regulatory Compliance Expert to join our team at TN Ireland. As a Regulatory Compliance Expert, you will be responsible for ensuring compliance with industry regulations and internal policies, as well as leading and supporting validation and change control processes.About the Company:TN Ireland is a leading...
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Compliance Expert for Pharmaceuticals
4 days ago
Cork, Cork, Ireland TN Ireland Full timeThe ideal candidate for this position at TN Ireland is a highly experienced Qualified Person with a strong background in regulated pharmaceutical environments. You will be responsible for ensuring the highest quality standards and compliance with regulatory requirements.Main responsibilities:Develop and implement quality control strategies to maintain...
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GxP Compliance IT Expert
8 hours ago
Cork, Cork, Ireland Cognizant Life Sciences Manufacturing Full timeWe are seeking a GxP Compliance IT Expert to join our team at Cognizant Life Sciences Manufacturing. In this role, you will be responsible for ensuring that our laboratory systems comply with Good Practice (GxP) regulations.Your primary responsibilities will include:Developing and implementing policies and procedures for GxP complianceConducting risk...
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Systems Compliance Expert
1 week ago
Cork, Cork, Ireland Westbourne It Global Services Full timeJob Overview:As a Systems Compliance Expert, you will be responsible for ensuring that our laboratory equipment meets regulatory requirements. This includes validating equipment to ensure it meets the necessary standards, developing and implementing validation protocols, and collaborating with cross-functional teams to ensure seamless project delivery.About...
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Regulatory Compliance Expert
5 days ago
Cork, Cork, Ireland Cook Medical Full timeCook Medical is seeking a seasoned Regulatory Compliance Expert to join our team and drive excellence in CMC. This critical role involves developing and implementing effective regulatory strategies, ensuring seamless collaboration across functions, and maintaining high-level expertise in FDA, USP, EP, and ICH guidelines.About the Role:Contribute to the...
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Analytical Scientist
1 day ago
Cork, Cork, Ireland Life Science Consultants (Lsc) Full timeLife Science Consultants is pleased to offer a contract opportunity for a Regulatory Chemist with 3+ years of experience in a GMP environment related field and a BS degree. If you're ready for your next challenge, this could be the perfect project for you.About the Company:LSC have a great contract opportunity for a QC Chemist with a large biopharmaceutical...
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GMP Instrumentation Technician
4 days ago
Cork, Cork, Ireland Life Science Recruitment Full timeJob OverviewThis role offers an opportunity to work as a GMP Instrumentation Technician in a biotech manufacturing environment. The successful candidate will provide equipment lifecycle management support to the QC Laboratories.Main DutiesEvaluate and select suitable equipment for the QC Laboratories.Develop and implement equipment qualification/validation...
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Quality Assurance Expert with GMP Experience
3 days ago
Cork, Cork, Ireland Hovione Full timeAbout UsHovione is an independent family-owned international group of companies with a long history of innovation and excellence in the pharmaceutical industry. Our team of over 1950 employees from 36 different nationalities, located across Asia, Europe, and North America, works together to deliver high-quality products and services to our customers.We are...
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GMP Analyst
3 days ago
Cork, Cork, Ireland SGS Full timeJob DescriptionAs a QC Analyst, you will be responsible for ensuring the quality and safety of pharmaceutical substances.Your main duties will include:Conducting testing and analysis of pharmaceutical substances.Ensuring compliance with clients' procedures and quality systems.Managing laboratory equipment and calibrations.Qualifications:Science Degree in...
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Outbound B2B Sales Development Executive
2 days ago
Cork, Cork, Ireland Compliance & Risks Full timeAbout UsWe are a pioneering organization at the forefront of market access and product compliance, dedicated to providing innovative SaaS solutions that empower businesses to navigate complex regulatory landscapes with confidence.Our team of experts works tirelessly to develop and maintain the world's most comprehensive database of legislative information,...
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Regulatory Compliance Expert
5 days ago
Cork, Cork, Ireland LSC, Life Science Consultants Full timeWe are seeking a highly skilled Pharmaceutical Quality Assurance Specialist to join our client's team in Cork.The successful candidate will have 2+ years of experience in a GMP regulated environment and exhibit knowledge or proficiency in a compliance or quality role. The ideal candidate is looking for their next challenge and is ready to support the testing...
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GMP Manufacturing Technicians
2 days ago
Cork, Cork, Ireland Cpl Healthcare Full timeCpl Healthcare is currently recruiting GMP Manufacturing Technicians to work in our client's Cork facility.The successful candidate will have experience working in a similar environment and possess excellent communication skills.Key responsibilities include supporting established manufacturing scheduling processes, handling raw materials according to...
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Regulatory Compliance Chemist
5 days ago
Cork, Cork, Ireland Life Science Consultants (Lsc) Full timeWe are seeking a highly skilled Pharmaceutical Laboratory Expert to join our team at LSC in Cork. This is a fantastic opportunity to work on cutting-edge projects in the biopharmaceutical industry, driving quality and compliance through expert laboratory practices.The key responsibilities include:Coordinates waste management, LEAN/Operational excellence, and...
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System Validation Expert
5 days ago
Cork, Cork, Ireland TN Ireland Full timeJob DescriptionThe System Validation Expert will ensure IFF Pharma Solution's compliance with company policies, procedures, and industry guidance.This role involves risk assessing systems, reviewing change requests and test scripts, drafting protocols, and initiating and reviewing GMP documentation revisions.Responsibilities:Coordinate with a...
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Regulatory Compliance Expert
7 days ago
Cork, Cork, Ireland Johnson & Johnson Full timeRole OverviewThe Regulatory Compliance Expert will be responsible for ensuring the development, manufacture, and distribution of biotherapeutics are in compliance with regulatory requirements. This role requires expertise in compendial testing and method ownership.Key ResponsibilitiesAct as a subject matter expert on large molecule methods, including pH,...
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Regulatory Compliance Expert
1 week ago
Cork, Cork, Ireland Johnson & Johnson Full timeJob OverviewThe Compendial Compliance Specialist position sits within the Physico-chemical Sciences and Sample Management team as part of the wider BTDS AD Department.As a Regulatory Compliance Expert, you will act as a Large Molecule, Subject Matter Expert (SME) solely responsible for ownership of compendial and particulates methods.Your primary focus will...