QA Specialist
1 month ago
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 activities. Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met. RESPONSIBILITIES: Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met .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.
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QA Specialist
1 month 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
4 weeks 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 II
4 weeks 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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Senior Specialist QA
4 weeks ago
Cork, Ireland Stryker Ireland Full timeQA Senior Specialist, UK & BNN Group: RAQA Division: EMEA Location: UK/Nordic/Benelux Position Summary Develops and appliessound knowledge and understanding of the QA frameworks, legislative requirements, processes and procedures in the EMEA distribution organisation. Responsible for developing and maintaining the QMS and ensuring compliance to the ISO9001...
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Senior Specialist QA
3 weeks ago
Cork, Ireland Stryker UK Limited Full timeWork Flexibility: Hybrid QA Senior Specialist, UK & BNN Group: RAQA Division: EMEA Location: UK/Nordic/Benelux Position Summary Develops and applies sound knowledge and understanding of the QA frameworks, legislative requirements, processes and procedures in the EMEA distribution organisation. Responsible for developing and maintaining the QMS and...
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QA Specialist
4 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
4 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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QA Specialist
5 months ago
Cork, Ireland Westbourne IT Global Services Full timeEssential Duties and Job Functions: ·Participates within inter-departmental and cross-functional teams ·Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements Reviews routine release documentation for Packaging Components & Starting Materials Reviews Supplier investigations, Temptales and disposal of...
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QA Specialist, External Quality
6 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
3 weeks ago
Cork, Ireland Kelly Services Full timeJob Title : Quality Assurance Specialist Location : Cork Contract Type: 12 Months Job Description: Our Pharmaceutical client is currently hiring for a QA Specialist on a 12 month contract. The role will require performing QA review of manufacturing and strong understanding of QA systems, procedures and methods. The ideal candidate Will have previous...
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Quality Assurance Specialist
1 month ago
Cork, Ireland Cpl Resources Full timeKenny-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...
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Quality Assurance Specialist
1 month 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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QA Specialist
6 months ago
Cork, Ireland Westbourne IT Global Services Full timeMain Purpose and Objectives of Position: ·Provide Quality leadership, direction and governance for the specific area of responsibility. ·Manage quality-related matters specific to area of responsibility ·Responsible for approving appropriate quality-related documents. Approval signature confirms that company and GMP requirements have been met. ...
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AML QA Specialist
5 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 Complaints Specialist
6 months ago
Cork, Ireland Westbourne IT Global Services Full timeThis experienced position requires requiring sound knowledge of quality assurance systems, methods and procedures. The candidate will lead product complaint investigations including coordinating the different investigation elements with site departments, completing detailed review of complaint samples against master files to determine authenticity,...
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Referral Laboratory Management Specialist I
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Cork, Ireland Pharmiweb Full timeReferral Laboratory Management Specialist I 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...
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Clinical Operations Manager
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Cork, Ireland Charlene Cooke Healthcare Recruitment Limited Full timeAn exciting opportunity has arisen to join in a front line operational management post within a Radiotherapy centre in Cork. Are you an Operations manager with a passion for leadership and a talent for driving Operational excellence? Meet your potential employer: Join one of the Most Extensive Networks of Cancer Specialists in the world! Drive Excellence in...
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Radiotherapy Operations Manager
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Cork, Ireland Charlene Cooke Healthcare Recruitment Limited Full timeJob Title: Radiotherapy Operations Manager Location: Cork Reporting to: Director of Oncology If you're a Highly experienced Radiotherapy Leader with a Passion for Innovation and Operational efficiency, this is your next career move! Meet your potential employer: Join one of the Most Extensive Networks of Cancer Specialists in the world! Drive Excellence in...
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DeltaV Automation Engineer
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Cork, Ireland Ampstek Full timeAmpstek supplies thousands of tech and digital professionals annually to a range of clients through its offices which spread across in 42 countries. From simple beginnings in 2014, Ampstek has always been on a journey to reinvent the world of recruitment through creating amazing customer and candidate experiences driven by a genuine desire to build long term...