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QA Officer

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Date: Sep 8, 2021

Location: Larne Millbrook, GB

Company: Terumo BCT, Inc.

Due to ongoing expansion we currently have vacancies for Quality Assurance Officers.  Based in Larne, the successful candidate will assist in the implementation, maintenance and review of the Quality System to current regulatory requirements.

 

QUALITY ASSURANCE OFFICER

(Ref No:  21/34)

 

 

 

Duties will include the following:

  • Assist in updating and maintaining the Quality System to the current requirements of GMP, ISO 13485 and 21 CFR Part 211.
  • Carry out batch document reviews for product manufactured for Terumo BCT Ltd.
  • Issue and control of controlled documentation for the Terumo BCT Ltd.
  • Ensure all planned changes or deviations have been notified and documented in accordance with written procedures.
  • Ensure all necessary quality records have been completed and endorsed by appropriately trained supervisors.
  • Statistical Analysis of data and generation of trends.
  • Conducting Internal audits and site spot checks.
  • Working under pressure to meet deadlines – (this role will necessitate working additional hours and shifts)
     
    Applicants must possess:
  • 3rd Level qualification (A scientific or quality-based discipline would be preferred but not essential)
  • At least 3 years’ experience within a quality role
  • Knowledge and experience of GMP and Quality Assurance Systems.
  • Previous experience in a manufacturing environment.
     
     
    It is also highly desirable that employees possess the following:
  • Knowledge of and experience in the pharmaceutical/medical device industry
  • Knowledge and experience of using a QMS.
  • Possess an Internal Auditor qualification for ISO 13485: 2016 or a Lead Auditor Qualification.
     
     

Please ensure your CV clearly demonstrates how you meet the criteria above as we cannot make assumptions on your experience and will base our decision on information provided.

If you would like to apply for this vacancy, please apply via our company recruitment portalbefore the closing date of 4.00 pm on Wednesday 15th September 2021, and quoting reference: 21/34.    

 

 

Terumo BCT Ltd is an Equal Opportunities Employer and welcomes applications from all sections of the community regardless of their gender, marital or family status, religious belief or political opinion, disability, race or ethnic origin, nationality, sexual orientation or age.


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