Senior GMP Auditor
2 days ago
As aGMP Quality Auditor you will be responsible for planning, coordinating and performing pre, during and post-audit activities for assigned audits. You will be responsible for assessing systems, processes, procedures and records against applicable U.S. and ex-U.S. GxP regulations, with primary emphasis on GMP, IT and quality audits that may impact Regeneron operations and/or product. A typical day might include, but is not limited to, the following: Maintaining professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and applicable local and international regulations, standards and guidelines (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc.) Supervising industry trends with respect to regulatory agency findings, expectations and warning letters Performing supplier/external audits and evaluating systems, processes, procedures and records against applicable GxPs and audit criteria Collaborating with procurement, external manufacturing, quality, audit clients and other stakeholders with respect to supplier/external audits Performing and maintaining all required training and annual GMP training within required timelines Performing required lead auditor or support auditor activities as applicable for assigned audits Preparing written audit reports and documents in accordance with company and department procedures and requirements; ensuring the quality and accuracy of all audit documentation; ensuring timelines for assigned audits are met Providing guidance and support in the development of corrective and preventive actions based on GxP requirements and industry standards Completing peer reviews of audit documentation and auditee responses; ensuring requirements for audit documentation and auditee responses are met Participating in IOPS inspection readiness, inspections/partner audits, and internal audits as needed Note this position requires approximately 50% travel, globally This role might be for you if: You have the ability to maintain integrity and honesty at all times You have the ability to work independently or as part of a team You have the ability to communicate with transparency You have previous experience as SME in highly regulated environment (e.g. pharma, biotech, medical devices) in both internal and external regulatory audits You have experience in understanding and interpreting regulatory guidelines and documents To be considered for this opportunity you must have a BS/BA with 5+ years of related experience in Biotech/Pharmaceutical industry. A minimum of 3 years of prior auditing experience in a GMP environment; experience in aseptic filling operations and supplier auditing is preferred. #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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Internal Auditor
3 days ago
Dublin, Ireland Saint John of God Community Services Clg Full timeSaint John of God Community Services clg. Saint John of God Community Services clg. provides services for people with intellectual disability in four regions of Ireland: two Dublin Regions, the North East and Kerry. The company also provides adult mental health and child and adolescent psychiatry services in the Dublin region. It provides a range of supports...
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Senior IT auditor, Dublin
3 days ago
Dublin, Ireland AIB Group Full timeRole Title: Senior IT Auditor - Group Internal Audit Location/Office Policy: Molesworth Street, Dublin 2 hybrid working, with the option of working from regional locations in AIB's Regional Hubs (Cork/Galway & Waterford) What is the Role: Group Internal Audit currently consists of approximately 100 audit professionals operating in Ireland and the UK. The...
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Senior IT Internal Auditor
14 hours ago
Dublin, Ireland FBD Holdings Full timeCompany description: FBD Holdings PLC Job description: Job Overview This job involves delivering and managing audit assignments across all IT areas in line with Internal Audit standards and requirements. You will spend your time conducting IT internal audits, reporting on areas of risk or weakness, preparing conclusions and recommendations for appropriate...
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FBD Holdings | Senior IT Internal Auditor
3 weeks ago
Dublin, Ireland FBD Holdings Full timeCompany description: FBD Holdings PLC Job description: Job Overview This job involves delivering and managing audit assignments across all IT areas in line with Internal Audit standards and requirements. You will spend your time conducting IT internal audits, reporting on areas of risk or weakness, preparing conclusions and recommendations for appropriate...
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Food Safety Auditor
2 days ago
Dublin, Ireland Dunnes Stores Full timeDunnes Stores is Ireland's leading retailer positioned at the cutting edge of food and fashion retailing. We are Irish owned and operate over 130 stores across Ireland, Northern Ireland, and Spain, as well as a growing online store. We are expanding our service and product offering for our customers all the time. We are currently looking for a food safety...
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Dublin, Ireland Saint John of God Community Services Clg Full timeSaint John of God Community Services clg. Saint John of God Community Services clg. provides services for people with intellectual disability in four regions of Ireland: two Dublin Regions, the North East and Kerry. The company also provides adult mental health and child and adolescent psychiatry services in the Dublin region. It provides a range of supports...
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IT Auditor
3 days ago
Dublin, Ireland Deloitte Ireland LLP Full timeDeloitte is the biggest professional services Firm in the world making an impact is more than just what we do: it's why we're here. We're driven to create positive progress for our clients, community, people, and the planet. This sense of purpose inspires us to work to the highest standards, to tackle the challenges that matter. Audit & Assurance is one of...
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Senior Associate QC
2 days ago
Dublin, Ireland Life Science Recruitment Ltd Full timeSenior Associate Quality Control 12 Months AS33795 Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. 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. Senior Associate Quality Control will be someone with a...
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Senior Qualified Person
3 days ago
Dublin, Ireland Helsinn Birex Pharmaceuticals Ltd Full timeSenior Qualified Person - QP Key Responsibilities: Certify and release batches of pharmaceutical products in compliance with EU GMP Annex 16, EU Directives 2001/83/EC and 2001/20/EC, and HPRA requirements, ensuring alignment with product Marketing Authorizations (MA). Lead and coordinate investigations into manufacturing deviations, non-conformances, and...
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Audit Senior
3 days ago
Dublin, Ireland Verde Search Full timeAudit Senior - Dublin - Career Progression A new Audit Senior opportunity has been created in a central Dublin based professional services firm. You will have a healthy work / life balance combined with training to support your career progression and development. The Audit Senior role can be based in the central Dublin office, with flexibility to work from...
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Senior CQV Engineer
2 days ago
Dublin, Ireland TEAM HORIZON Full timeTeam Horizon is seeking a Senior CQV Engineer for a leading pharmaceutical company in South Dublin. Why you should apply: ? This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses. ? There is a strong...
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IT Auditor
3 days ago
Dublin, Ireland Deloitte Ireland LLP Full timeDeloitte is the biggest professional services Firm in the world and making an impact is more than just what we do: it's why we're here. We're driven to create positive progress for our clients, community, people, and the planet. This sense of purpose inspires us to work to the highest standards, to tackle the challenges that matter. About the Role: The...
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Audit Senior
3 days ago
Dublin, Ireland Artemis Human Capital Full timeArtemis Human Capital are delighted to be partnering with this top 10 accountancy practice in Dublin to appoint 3 audit seniors. This business caters to a wide and interesting variety of sectors across Ireland. Role Overview You will play a key role in managing and executing audits from planning through to completion. This position involves working closely...
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Senior Manager Sustainability
2 days ago
Dublin, Ireland Cpl Resources Full timeSenior Manager Sustainability & ESG About the Role Our client, one of the largest Airline Groups in the world are looking for an accomplished and proactive Senior Manager to lead their Sustainability and ESG initiatives. This role is based at their headquarters in Dublin and reports directly to the Deputy Director of Sustainability & Finance. The ideal...
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TEAM HORIZON | Senior CQV Engineer
4 weeks ago
Dublin, Ireland TEAM HORIZON Full timeTeam Horizon is seeking a Senior CQV Engineer for a leading pharmaceutical company in South Dublin. Why you should apply: ? This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses. ? There is a strong...
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INFORM3 Recruitment | Automation
3 weeks ago
Dublin, Ireland INFORM3 Recruitment Full timeJob Title Automation & Maintenance Manager Job Location West Dublin Salary Competitive Based on Experience About the Company: Are you an Automation and Maintenance individual with management experience? Then this is the role for you. The role of the Automation & Maintenance Manager is to oversee all installation, day to day running, repair, breakdowns, and...
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Automation & Maintenance Manager
3 days ago
Dublin, Ireland INFORM3 Recruitment Full timeJob Title Automation & Maintenance Manager Job Location West Dublin Salary Competitive Based on Experience About the Company: Are you an Automation and Maintenance individual with management experience? Then this is the role for you. The role of the Automation & Maintenance Manager is to oversee all installation, day to day running, repair, breakdowns, and...
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Senior Cost Accountant
14 hours ago
Dublin, Ireland FRS Recruitment Full timeFRS are partnering with an Award-winning business who play a major role in supplying hospitals and laboratories with life changing equipment to assist with diagnosis of medical conditions across the globe. This is an opportunity for a Qualified Accountant with demonstrated experience in Cost Accounting to join a global finance team. You will work in a...
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Quality Control NPI Senior Associate
3 days ago
Dublin, Ireland Life Science Recruitment Ltd Full timeQuality Control NPI Senior Associate 12 Months Dun Laoghaire AS33640 Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. 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. Quality Control NPI Senior Associate will...
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Senior Cost Accountant
3 days ago
Dublin, Ireland Martina Quinn Finance Recruitment Full timeSenior Cost Accountant Dublin Multinational Location: Dublin, Ireland Salary: €80,000 - €85,000 Employment Type: Full-Time, Hybrid Company Overview We are delighted to partner with a leading multinational organization renowned for its commitment to innovation, employee development, and sustainable practices. Based in Dublin, this company offers a...
