Quality Assurance Specialist
2 weeks ago
Kenny-Whelan (a specialist division of the CPL group) are hiring aQA Specialist to support the Maintenance Department, to work on contract atJanssen in Ringaskiddy Cork- ContactJenn Dinan onoremail New vacancy OCT 2024 MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it QA SPECIALIST -Support the Maintenance Department Looking for previousexperience in a GMP environment, previous QA experience & experience in non-conformance investigations ?Position Summary: This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at Janssen Biologics as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review and Validation compliance activities. Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met. GENERAL SCOPE OF RESPONSIBILITIES: Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model. Partners with other Departments to ensure that compliance systems are implemented in an efficient manner. Duties Batch Record Review & material release to ensure compliance with GMP requirements. Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints. Carries out tasks related to the management of batch records design and approval. Carries out administration of the SAP Quality Management Module. Carries out tasks relating to the management of site change control systems. Compiles Annual Product Reviews. Supports all validation activities on site as described in the Site Validation Master Plan. Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.). Supports system qualification and process validation activities. Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site. Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI) Perform GMP audits on-site and vendor facilities as required. Performs on the floor walkdowns regularly to ensure process and facilities are maintained to GMP standards. Carries out tasks related to the administration of site supplier approval process. Key Skills and Competencies required: Excellent interpersonal skills Ability to operate as part of a team is critical. Customer focus Innovative Excellent communication skills both written and verbal Attention to detail Good problem solving skills Results and performance driven Adaptable and flexible Decision making QUALIFICATIONS AND EXPERIENCE: ESSENTIAL- Quality Assurance Specialist-QA Operations: Bachelors Degree in a scientific/technical discipline required A minimum of 3-5 years experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA and other authorities. DESIRABLE: Experience in auditing of external suppliers, contractors and vendors MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it All applications will be treated with the strictest of confidence. Contact Jenn Dinan on Skills: CAPA Change controls Non-conformances QA cGMP Biopharmaceuticals Benefits: Paid Holidays Parking Staff Discounts
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Quality Assurance Specialist
2 weeks ago
Cork, Ireland RT Lane Ltd Recruitment Full timeR.T. Lane Recruitment are currently recruiting for QA Specialists to work with a pharmaceutical company based in Cork. This is a 12-month contract with strong potential for extension. **Please note that candidates must hold the correct working visa for Ireland and be currently living in Ireland as my client cannot offer visa assistance** The successful...
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Senior Quality Specialist
3 months ago
Cork, Ireland Endo Operations Limited Full timeDescription The Senior Quality Specialist, Quality Operations has responsibility for overseeing quality in Contract Manufacturing Quality Operations and Quality Management Systems (all aspects), as well as handling Corrective and Preventive Actions (CAPA). May manage projects or serve as a designee to the Subject Matter Expert (SME) or Process Owner...
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AML QA Specialist
4 months 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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QA Specialist, External Quality
5 months ago
Cork, Ireland BioMarin Full timeWho We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled...
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Quality Assurance Specialist
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Cork, Ireland Westbourne IT Global Services Full timeMain Duties & Responsibilities · Provides clerical and administrative support related to GxPlearn and GVault. · Responsible for Archiving, filing and maintenance of training related documents. · Maintains documentation manuals to ensure accuracy and current information. · Ensure the correct and timely input of training related documents into the...
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Quality Systems Specialist
2 weeks ago
Cork, Ireland Cpl Resources Full timeKenny-Whelan (a specialist division of the CPL group) are hiring anotherQuality Systems Specialistto work on contract atJanssen in Little Island Cork HYBRID Role - 3 days onsite ContactJenn Dinan onoremail New vacancy Oct 2024 MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on...
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QA Specialist
2 weeks ago
Cork, Ireland RT Lane Ltd Recruitment Full timeQA Specialist urgently required for a busy Pharmaceutical Manufacturing site in Cork. Experience of Batch Record review, Projects and Operations. Would suit someone with at least 3 years experience gained within a Pharmaceutical Operations environment. Apply today for more details Duties Batch Record Review & material release. Carries out tasks related to...
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QA Specialist II
6 days ago
Cork, Ireland Harry Walsh Associates Ltd. Full timeQA specialist required for a 12 month contract with a leading pharmaceutical client. This specific role is required to perform QA review of manufacturing, QC and engineering records & associated documents and QA review & approval of procedures and GMP deviations. This position requires a sound knowledge of quality assurance systems, methods and procedures....
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QA Specialist
3 months ago
Cork, Ireland Life Science Recruitment Ltd Full timeQA Specialist RK9352 Contract 12 months Cork Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. This position is responsible for carrying out tasks and projects...
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QA Specialist
2 weeks ago
Cork, Ireland Claran Consultants Ltd Full timeThis position is responsible for carrying out tasks and projects related to management of Quality Assurance activities as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review and Validation compliance activities....
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QA Specialist II
6 days ago
Cork, Ireland CareerWise Recruitment Full timeA QA Specialist is required on an initial 12-Month basis by CareerWise Recruitment for our Cork-based multinational research-based pharmaceutical Company. This role is a QA Specialist II, role in the GSIUC QA Department, under the QA General Operations team. This specific role is required to perform QA review of manufacturing, QC and engineering records &...
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QA Specialist
3 months ago
Cork, Ireland PE Global Full timePosition Summary: This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review and Validation compliance...
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Packaging QA Specialist
2 weeks ago
Cork, Ireland Catalyx Full timeCatalyx is seeking a QA Specialist to join our team and work on our customer site in Cork on a6-month contract. The QA Specialist is responsible for the creation, revision, and delivery of GMP documentation to our FDA-regulated customers. Catalyx specialises in the science of operational processes. With a footprint across North America and Europe, the...
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Haematology Specialist
3 weeks ago
Cork, Ireland Pharmiweb Full timeHaematology Specialist ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. At ICON, it’s our people that set us apart. Our diverse teams enable us...
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Haematology Specialist
5 days ago
Cork, Ireland Pharmiweb Full timeHaematology Specialist ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. At ICON, it’s our people that set us apart. Our diverse teams enable us...
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Site Manager
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Cork, Ireland Construction Specialist Recruitment Full timeSite Manager Cork CSR group is looking for an experienced Site Manager for a healthcare project in County Cork. The company is one of Irelands leading Main Contractors that have projects running all over the country. They strive to provide the highest quality of projects consistently delivering them on time and to the highest quality. They are looking to...
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Process Specialist
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Cork, Ireland Pfizer Ireland Pharmaceuticals Full timeProcess Specialist Ringaskiddy API site in Cork plays a critically strategic role within Pfizer, it is the global site for new small molecule API products through scale up and launch, as well as manufacture of large volume patented and off-patent medicines. Colleagues on the site use state of the art equipment and leading-edge technology, as well as work...
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Software Quality Lead
9 hours ago
Cork, Ireland Motorola Solutions Full timeJob Description The Software Quality Lead will report to the Sr. Manager of Software Quality within the Supply Chain function and will support Motorola LMR Products and Services. This individual will be a “change agent” and will integrate quality checks throughout the development cycle of software tools and applications. This individual will be...
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Staff Engineer, Design Assurance
3 weeks ago
Cork, Ireland Stryker Ireland, Ltd. Full timeWork Flexibility: Hybrid What you will do: Lead risk management and usability activities for Joint Replacement products currently in the field in accordance with ISO 14971 and IEC 62366. Define strategy and execute on emerging issues (NC/CAPA, Regulatory Requests), Joint Replacement Lifecycle Management (Product Transfers, Supplier Initiated Change...
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Manufacturing Process Specialist
2 weeks ago
Cork, Ireland CareerWise Recruitment Full timeAn Upstream Manufacturing Process Specialist is required by CareerWise Recruitment to join our Cork based Biotech client - 12 month initial contract role. The role will have responsibility for the day to day production of products, act as a point of contact for a product (product owner). Trending of process parameters and managing non-conformances. ROLE: *...