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Senior QA Officer

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Date: Jan 15, 2022

Location: Larne Millbrook, GB

Company: Terumo BCT, Inc.

Senior QA Officer

(Ref No:  21/59)

 

Terumo BCT Ltd - located in Larne - manufactures a range of sterile fluids for human and veterinary use.    Vacancy currently exists for the role of Senior QA Officer.    The successful candidate will assist in the implementation, maintenance and review of the Quality System to current regulatory requirements.  

Duties will include:

  • Ensuring that the Quality System is updated and maintained to GMP, ISO 13485 and CFR Part 211.
  • Assisting in the smooth running of the QA department by organising the workload of the team in the most efficient manner.
  • Ensuring batch documentation reviews are completed in timely manner for compliance and ensuring that all products are manufactured in accordance with the relevant licensing requirements.
  • Reviewing responses to planned changes and assessing suitability of these prior to approval. 
  • Reviewing and investigating internal and external quality complaints, ensuring corrective actions are implemented and reporting on any trends that exist. 
  • Ensuring all out-of-specification results and unplanned non-conformances are fully investigated and documented and any corrective or preventative actions identified are appropriate. 

 

Applicants must possess:

  • 3rd Level Qualification  in a relevant science or engineering subject
  • Minimum of three years work experience in a GMP manufacturing environment
  • A good working knowledge of relevant GMP regulations and requirements
  • Experience in auditing to GMP standards and in being audited
  • Ability to work with cross-functional teams
  • Ability to review others’ work and draft reports/validation reviews
  • Able to work additional hours as and when required

 

It is desirable that employees possess the following:

  • A degree or Master’s degree in Chemistry or Microbiology
  • Recognised auditing qualification
  • Experience in sterile Pharmaceutical or Medical Device product manufacture
  • CAPA processing, continual improvement, including Root Cause Analysis

If you would like to apply for this vacancy, please submit an up-to-date copy of your CV via mySource - to arrive before the closing date/time of 5:00 pm on Friday 21st January 2022    


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