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Search Results for QA Specialist
Job Title. | Location | Salary | Actions |
Reg Affairs SpecialistRole: Regulatory Affairs Engineer Location: Parkmore, Galway (Hybrid working) Benefits: Top salary Company: My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore. They have developed an innovative new technology to improve the performance of Vascular stents. Role: Reporting to the Senior Regulatory Affairs Manager, as a Regulatory Affairs Specialist you will play a key a key role in the implementation of post-market activities within Veryan. This is a ...Location: Connaught, Galway, Galway City, Leitrim, Limerick, |
EU | Not Disclosed | |
Quality EngineerJob title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Quality SpecialistJob title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m...Location: Clare, Limerick, Limerick City, Republic of Ireland, |
EU | Not Disclosed | |
Quality SpecialistJob title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m...Location: Clare, Limerick, Limerick City, Republic of Ireland, |
EU | Not Disclosed | |
Quality SpecialistJob title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m...Location: Clare, Limerick, Limerick City, Republic of Ireland, |
EU | Not Disclosed | |
Quality EngineerRole: Quality Engineer Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension, healthcare and hybrid working Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training. Responsibilities Assist with the implementation and development of the site QMS in line with the ...Location: Athlone, Connaught, Leitrim, Longford, Midlands, |
EU | Not Disclosed | |
Quality EngineerRole: Quality Engineer Location: Mullingar, Westmeath (On site) Benefits: Good salary, pension, healthcare and yearly bonus. Company: My client are an exciting business located in a modern state of the art facility in Mullingar Co. Westmeath. Passionate about serving the world’s medical device and allied healthcare industries in offering a range of the highest quality innovative healthcare packaging solutions. Role: Reporting to the Senior Quality engineer and/or Quality and Regulatory Director the Quality Engineer will work in collaboration with the s...Location: Athlone, Cavan, Dublin, Kildare, Longford, |
EU | Not Disclosed | |
Quality Systems ManagerCompany: My client are have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. They are committed to helping create healthier communities worldwide through education, outreach and better access to treatment Role: Quality Systems Manager - Senior Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17 Team: 6 direct reports Hybrid working: 2-3 days a week on site per week Benefits: Compe...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | Not Disclosed | |
Quality EngineerRole: Quality Engineer Location: Mullingar, Westmeath (On site) Benefits: Good salary, pension, healthcare and yearly bonus. Company: My client are an exciting business located in a modern state of the art facility in Mullingar Co. Westmeath. Passionate about serving the world’s medical device and allied healthcare industries in offering a range of the highest quality innovative healthcare packaging solutions. Role: Reporting to the Senior Quality engineer and/or Quality and Regulatory Director the Quality Engineer will work in collaboration with the s...Location: Athlone, Cavan, Dublin, Kildare, Longford, |
EU | Not Disclosed |
Career Profile
Quality Assurance Specialist
Quality Assurance is responsible for gathering and collating data from the various departments of the Pharma manufacturing site and preparing for batch approval by the Qualified Person (QP).Key Responsibilities of the Quality Assurance Specialist
The position is responsible for carrying out tasks and projects related to managing QA activities related to the site as required by GMP. These activities include change control, nonconformance investigation, raw material and batch release, quality systems auditing, and validation review activities .
Role/Opportunity:
- Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.Supports the development and management of GMP QA systems
- Develop and implement processes, procedures, forms, work instructions and tools related to the implementation of quality systems at the site.
- Assesses QA systems on ongoing basis to identify opportunities for process improvement.
- Reviews and/or approves nonconformance investigations and their associated documentation.
- Carries out tasks related to the management of project and site change control systems
- Review and approval of qualification/validation documentation.
- Carries out administration of the Supplier Assessment, Auditing and Inspection Readiness Systems at the site
- Reviews and approves SOPs/work instructions/forms/validation plans from other departments on behalf of Quality Assurance.
- Support QA activities for new product introductions
Skills/Experience
- BSc essential
- A minimum of 2 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.
- Experience in development/and or evolution of GMP systems is desirable
Healthcare Regulatory Affairs Clinical Research R and D Manager Quality Systems Lead Engineering Manager Contract Leitrim Regulatory Affairs Specialist Limerick City Cork Senior Project Manager QA Validation Specialist Kildare Validation Specialist Senior Research and Development Engineer Regulatory Affairs Lead Quality Engineer Clinical Research Validation Engineer QA Specialist Clare Athlone QA Engineer Medical Affairs Scientific Quality Assurance Biopharmaceutical Midlands Regulatory Affairs Director Research and Development Supply Chain Connected Health QA RA Engineer QA Manager Manufacturing and Technology Manager Quality Specialist Galway Quality Systems Engineer Microbiology Galway City Dublin R and D Director Republic of Ireland Offaly Life Science Longford Regulatory Affairs Consultant Business Development Executive Regulatory Affairs Biotechnology Pharmaceutical Research Fellow Roscommon Contract Sligo Snr Validation Engineer Connaught Quality Engineer Snr R and D Engineer Regulatory Affairs Executive Supply Chain Engineering QE Manufacturing Engineer Regulatory Affairs Manager Medical Device EHS Engineer Engineering Quality Systems Specialist Senior Regulatory Affairs Officer Senior Quality Engineer Technical Specialist Project Manager Regulatory Affairs Officer Limerick Supplier Quality Engineer Westmeath EHS Specialist BD Manager Quality Manager Design Assurance Life Science
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Regulatory Affairs | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected]
Copyright © 2012 Life Science Recruitment Ltd
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Regulatory Affairs | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected]
Copyright © 2012 Life Science Recruitment Ltd
This site uses cookies. For more information on our cookie policy read our Privacy Policy | Terms of Use
Registered as a private limited company. No: 445328 | Web Design / SEO by WebScience | Valid XHTML - CSS







