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QA Release Officer

Job Description

Do you want to shape and contribute to the future of healthcare? Siemens Healthineers are looking for a QA Release Officer to join their Healthcare Diagnostics business based at the well-established and modern facility in Llanberis, located next to Snowdonia National Park. The facility manufactures and distributes reagents for in-vitro diagnostic medical devices used in hospitals worldwide to aid the diagnosis of medical conditions. 

This role can be based from home with occasional travel to our site.

The QA Release Officer will ensure products made available for sale comply with:

- manufacturing and testing requirements

- in-process and release specifications

- the regulatory requirements 

This role reports directly to the Quality Release Manager

Responsibilities: 

  • Reviewing manufacturing documentation to confirm that the product was manufactured in line with the requirements of the DMR to ensure both customer and regulatory requirements are met
  • Reviewing testing documentation to confirm that the product was tested in line with the requirements of the DMR to ensure both customer and regulatory requirements are met
  • Assigning of Kit Literature included with each product released in line with the DMR requirements to ensure that customers are supplied with the appropriate Kit Literature when using the product
  • Liaise with document owners to resolve issues or non-compliances identified during the review process and ensure that they are resolved prior to release to ensure only compliant products are released
  • Produce and publish reports on the quality of the documentation reviewed to provide feedback on current performance and drive future improvements
  • Liaising with documentation owners to identify documentation improvement opportunities to increase the quality and compliance of generated documents
  • Co-ordinate the archiving of completed DHR's to facilitate the prompt retrieval of requested DHR's
  • Continually assess the processes used within the QA Release Group for appropriateness and identification of non value added activities to ensure compliance and continuous improvement of the QA Release process 

Skills & Experience: 

  • Educated to 'A' level standard / equivalent vocational training and/or have equivalent time served experience within a Quality, Scientific or Engineering environment.
  • Awareness of working in a GMP environment
  • Ability to communicate with all areas of an organisation
  • Perform work in compliance with established procedures
  • Understanding of computer software including Word, Excel and Access
  • Must be able to demonstrate a good attention to detail 

Being part of our team:

In Llanberis, Siemens Healthineers is the sole manufacturer of IMMULITE reagents, used in IMMULITE blood analysers to aid the diagnoses and treatment for patients – more information can be found here

Siemens Healthineers has been Certified™ as a ‘great place to work’.  We are inspired to transform the way things are done – because we want what is best for our people, our customers, and ultimately to help everyone live longer and healthier lives. To find out more about our business and recent news, including our continued response to COVID-19, please explore our website

Benefits:

  • A competitive salary
  • Generous pension contributions
  • 26 days holiday
  • Access to our flexible benefits from private medical insurance to dental cover
  • Corporate Social Responsibility opportunities including 2 paid volunteering days per year
  • Support from our 24/7 employee assistance programme

 In addition, we provide a flexible and dynamic environment with the space to stretch beyond your comfort zone in order to grow both personally and professionally. Our unique team spirit arises from embracing different perspectives, open debate, and the will to challenge conventions. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we want you to seek, implement and celebrate your best ideas.


Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Products Ltd

Experience Level: not defined

Job Type: Full-time

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