QA Specialist
5 days ago
Position Summary: The position will be located at the Little Island site and will be part of the Quality Team. This position is responsible for Quality Risk Management and Quality Systems compliance activities as required by Good Manufacturing Practice (GMP). Main duties and responsibilities: The key elements of the role can be broken down into the following clusters: Execution of the Quality Risk Management (QRM) & Site Quality Risk Register (SQRR) processes ensuring effective governance, communication and management systems are in place and maintained. Execution of the Quality Internal & External Audit/Inspections preparation and management processes for the Site (including follow up on audit action completion, associated CAPAs, and NC Quality approval). Participate in Site risk assessments. Execute site and quality driven improvement projects as per the site Risk Register e.g. but not limited to, Supplier Qualifications. Reclassification of plant areas. Site Data Integrity Program Manages projects effectively to meet strict timelines and achieve established milestones with regular updates to Quality and Site Leadership Teams. Quality Review and Approval of SOPs, Work Instructions and forms from other departments and periodic reviews. Responsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a Quality perspective. Quality review and approval of quality non-conformance (NC) records. Quality point of contact for attendance at Root Cause Analysis meetings. Initiation and ownership of Quality non-conformance records. Quality assessor, reviewer and approval of quality non-conformance (NC) records. Key Skills and Competencies required: Builds strong productive relationships. Demonstrates ability to work with teams and individuals. Seeks opportunities to grow and develop professionally. Uses best practices to improve business operations. Holds self-accountable for compliant and flawless execution. Takes personal responsibility for decisions that successfully build customer value. Effectively manages and adapts to change. Always demonstrate Integrity and Credo-based actions. Education and Experience: Third level Degree in a science or pharmaceutical discipline. A minimum of 3 to 5 years experience in a quality or compliance role within the biological and/or pharmaceutical industry. Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities. Skills: Risk Management QRM Site Quality Risk Register SQRR Compliance HPRA FDA
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QA Validation Specialist
4 weeks ago
Cork, Ireland QA Resources Full time[fusion_builder_container type="flex" hundred_percent="no" hundred_percent_height="no" min_height="" hundred_percent_height_scroll="no" align_content="stretch" flex_align_items="flex-start" flex_justify_content="flex-start" flex_column_spacing="" hundred_percent_height_center_content="yes" equal_height_columns="no" container_tag="div" menu_anchor=""
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QA Specialist
5 days ago
Cork, Ireland Life Science Consultants (LSC) Full timeLSC have a great contract opportunity for a QA Specialist to join a pharmaceutical company in Cork. If you have 3 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Batch Record Review and material release...
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QA Packaging Specialist
5 days ago
Cork, Ireland Life Science Consultants (LSC) Full timeLSC have an exciting opportunity for a QA Packaging Specialist where you will be part of a dynamic team dedicated to delivering high-quality pharmaceutical products. You'll have the opportunity to work on cutting-edge projects, collaborate with cross-functional teams, and contribute to continuous improvement initiatives. As a QA Packaging Specialist, you'll...
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QA Specialist II
3 weeks ago
Cork, Ireland Gilead Sciences, Inc. Full timeAt Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges,...
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QA Packaging Specialist
5 days ago
Cork, Ireland Claran Consultants Ltd Full timeRole This position within the QA department provides Quality support and knowledge to activities relating to Quality to meet business priorities. The QA Specialist promotes Quality across cross functional teams, to deliver high quality products, ensuring continuous process improvement. The QA Specialist models the behaviours and understands the principles to...
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QA Compliance Specialist
4 weeks ago
Cork, Ireland Life Science Consultants (LSC) Full timeLSC have a great contract opportunity for QA Compliance Specialist to join a leading Cork based pharmaceutical company. ABOUT THE PROJECT - KEY RESPONSIBILITIES: Provide Quality leadership, direction and governance Manage quality-related matters Is responsible for approving appropriate quality-related documents. Carry out day-to-day activities in compliance...
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Cork, Ireland The Language Business Full timeA leading technology company seeks Multilingual Software QA Localisation Specialists in Cork, Ireland. Successful candidates will perform localisation testing on software and hardware while ensuring top-quality user experiences. Fluency in one of several specified languages is required. The role includes strong collaboration in an innovative environment, and...
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Senior QA Specialist
19 hours ago
Cork, Ireland Westbourne IT Global Services Full timeA prominent IT services firm in Cork is seeking a QA Specialist to ensure compliance with quality standards and manage supplier quality issues. The ideal candidate will have a strong background in the pharmaceutical industry, with over 3 years of experience in a GMP environment. The role involves reviewing Supplier qualifications, managing Quality...
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QC Lab Validation Specialist
2 weeks ago
Cork, Ireland QA Resources Full timeOverview The role would be for a QC equipment validation Specialist role, specifically involving the full qualification of a bench top Near-Infrared (NIR) spectrometer. The managers specifically want someone at a senior level that can take full ownership of the project, ensuring timelines and schedules are met. The scope of work would include, but is not...
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GxP QA Validation Specialist
2 weeks ago
Cork, Ireland DPS Group Global Full timeA leading pharmaceutical firm in Ireland, Munster is seeking a QA Validation Specialist. The ideal candidate will have a BSc or equivalent qualifications, with strong reviewing skills and attention to detail. Responsibilities include managing GxP validation activities, ensuring compliance with regulatory requirements, and participating in project teams...