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Search Results for QA Specialist
Job Title. | Location | Salary | Actions |
Quality Assurance Specialist (hybrid)Quality Assurance Specialist (hybrid) RK4599 Contract 12 months Dublin We’re 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. Duties: Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet company and regulatory e...Location: Dublin, |
Dublin | Not Disclosed | |
Senior QA Specialist (hybrid)Senior QA Specialist (hybrid) RK23762 11 Months Tipperary We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. 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. As a Senior QA Specialist, you will be a key driver of quality assurance activities at our site, ensuring that all operations align with cGMP principles and regulatory expectations from agencies such as the FDA and EMEA. You will take ownership of main...Location: Tipperary, |
Tipperary | Not Disclosed | |
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 |
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
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Copyright © 2012 Life Science Recruitment Ltd
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Contract Jobs | Tel:+353 1 685 4545 | Fax: +353 (0)1 443 05 24 | Email: info@contractjobs.ie
Copyright © 2012 Life Science Recruitment Ltd
This site uses cookies. For more information on our cookie policy visit our Privacy Policy | Terms of Use
Registered as a private limited company. No: 445328 |
Web Design / SEO by WebScience | Valid XHTML - CSS







