QA Officer - Gateshead, United Kingdom - CY Partner

CY Partner
CY Partner
Verified Company
Gateshead, United Kingdom

1 month ago

Tom O´Connor

Posted by:

Tom O´Connor

beBee Recruiter
Description

Salary:
c. £24,000 - £26,000


Location:
Gateshead


Contract:
Permanent


Start Date:
Immediate


Are you looking for Quality Assurance opportunities within the Biotechnology and Life Science Industries? A fantastic opportunity to join a growing Biotech company based in Gateshead has recently come available.


As a
QA Officer, you will be responsible for maintaining the Quality management system, ensuring that the manufactured products are produced and distributed in accordance with the correct Standards and regulations.


Your responsibilities will include:


  • Maintenance of the Quality Management System in compliance with appropriate International Standards & Regulations for the manufacture of IVD products. As well as evaluation and improvement of QMS.
  • Review batch manufacturing records to ensure adherence to requirements leading to the QA Release of products. Additionally, assist in nonconformance investigations, root cause analysis and implementing CAPA for process concerns.
  • Work with R&D and Operations departments to ensure the efficient and compliant transfer of new products from R&D to production.
  • Assessment and approval of changes to ensure quality impact analysis, risk management and validation activities are identified and carried out.
  • Conduct internal quality audits and assist with external audits.
  • Investigation and analysis of failure, corrective and preventive action to respond to customer complaints. Including assessment of potential reportable events, suppliers/distributors assessments, approval and reevaluation.
  • Creation, maintenance and approval of all QMS documentation, including archiving and reviews, assist in training and promoting QA awareness throughout the company.
  • Completion and analysis of QA Metrics towards Quality Management Reviews.
  • Deputise for QA Lead and assist in the delivering of training to build quality awareness.
  • Review, approval and administration of Product Notifications as well as preparation of preparation of post market surveillance reports.
  • Monitor the progress of quality activities on a daily/weekly basis ensuring that there is continuous drive/focus on meeting target dates and KPIs. As well as administration of online training system.

About you:


  • You will hold a relevant Scientific degree.
  • Excellent data analysis skills, as well as great attention to detail.
  • Knowledge and competency in using Microsoft and other software.
  • Demonstratable knowledge of medical devices or scientific industries. As well as ISO 1348
  • Effective attention to detail and the ability to work well in a team or independently.
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