▷ [Urgent Search] Senior QA Compliance Specialist
2 weeks ago
ithin this role you'll be responsible for maintaining the site's compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. As a Sr / Quality Compliance Specialist, a typical day might include, but is not limited to, the following: Being responsible for ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management. Administrating and oversight of site quality systems including but not limited to; Deviations CAPA Change Control Audits Customer Complaints Quality Risk Management Reviewing and approval of the following types of documents, relating to area functions: failure investigations change control documents corrective/preventative action documents standard operating procedures Maintaining electronic systems used for Change Control and Deviation Management Reviewing procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements Monitoring and trending metrics associated with site quality systems Participate in continuous improvement initiatives Participating in regulatory and customer audits Participating in quality risk assessments Collaborating with functional departments to resolve issues and maintain compliance Identifying gaps in systems and develop feasible plans for correction Training of personnel on quality system processes This role might be for you if you: Have proven experience in conducting on-site investigations and analysis (GEMBA walks) Have the ability to identify and address operational inefficiencies Have a track record of implementing process improvements based on findings from direct workplace engagement Can demonstrate respectful behaviour at all times Have basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint To be considered for this positon you must hold: Specialist: BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years of relevant work experience in pharmaceutical or related industry Senior Specialist: BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of relevant work experience in pharmaceutical or related industry #JOBSIEPR #REGNIEQA Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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QA Validation Specialist New
2 weeks ago
Limerick, Ireland CPL Full timeQA Validation Specialist Summary: The QA Validation Specialist ensures that equipment, computerized systems, facilities, and utilities are qualified and maintained in compliance with regulatory, company, and quality standards. This role provides quality oversight, technical support, and continuous improvement input to sustain the site’s validated...
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QA Validation Specialist
1 week ago
Limerick, Ireland Cpl Full timeQA Validation SpecialistSummary:The QA Validation Specialist ensures that equipment, computerized systems, facilities, and utilities are qualified and maintained in compliance with regulatory, company, and quality standards. This role provides quality oversight, technical support, and continuous improvement input to sustain the site’s validated state.Key...
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▷ (Urgent) Temp QA Specialist
3 weeks ago
Limerick, Ireland Regeneron Ireland Full timeWithin this role you'll be responsible for performing activities in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. This is a 12-month temporary contract. A typical day might include, but is not limited to, the...
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Limerick, Ireland Kenny-Whelan Full timeEnvironmental Compliance Specialist Kenny-Whelan are hiring an Environmental Compliance Specialist for one of its Global Life Science Companies in Limerick. Contact:Carmel Synnott : or call on Profile of the Role: The Environmental Compliance Specialist will be part of a team that will implement the requirements/conditions set out in the sites IED...
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Limerick, Ireland Cook Medical Incorporated Full timeOverview The Senior Manufacturing Engineering Specialist is responsible for the preventative maintenance schedule of equipment used in production and engineering. This person is also seen as a subject matter expert for equipment issue resolution and equipment performance improvement. Position: Senior Manufacturing Engineering Specialist Department:...
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Senior Associate Qa For Qc
3 weeks ago
Limerick, Ireland Eli Lilly And Company Full timeOverviewAt 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 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...
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Limerick, Ireland Regeneron Ireland Full timeWithin this role you will be responsible for providing QA oversight and support to manufacturing activities, performs and leads activities in support of product release in accordance with mandated regulatory requirements, applicable policies and procedures as well as site expectations. This role requires to work shift which includes a mix of days & nights....
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Environmental Compliance Specialist
3 weeks ago
Limerick, Ireland Lsc, Life Science Consultants Full timeConnecting you with projects at the cutting-edge of the Life Science IndustryWe have several contract opportunities available with global Biopharmaceutical companies in Ireland.Our current openings include:Technical Specialist: Join a global Biopharmaceutical company in Cork specializing in fermentation, purification, and other activities.Environmental...
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Legal Entity Specialist
19 hours ago
Limerick, Ireland ACCA Careers Full timeOverview Legal Entity Specialist - Governance & Compliance (1LOD) role at ACCA Careers. Northern Trust is seeking a highly experienced Specialist to join the Legal Entity Administration function. This role is critical in ensuring that Northern Trust’s legal entities across North America and EMEA operate in full compliance with global standards while...
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Environmental Compliance Specialist Limerick
2 weeks ago
Limerick, Ireland Kenny-Whelan & Associates Full timeEnvironmental Compliance Specialist Kenny-Whelan are hiring an Environmental Compliance Specialist for one of its Global Life Science Companies in Limerick. Contact:Carmel Synnott : csynnott@kenny-whelan.ie or call on 087 7422268 Profile of the Role: - The Environmental Compliance Specialist will be part of a team that will implement the...