QA Officer
Thermo Fisher Scientific, Inc.
Swindon, United Kingdom
28d ago

How will you make an impact?

Reporting to the QA Team Lead the successful applicant will join one of our Condo Clients working closely with Production and Engineering to ensure new products are manufactured in accordance with cGMP

Acting as first line of contact for operational quality advice and support for your Condo you will play a key role in driving early detection to help prevent potential quality issues.

Key Accountabilities

As a QA Officer you will be part of a multi-functional Condo responsible for implementing quality systems and related processes from project phase (equipment and process validation) to full cGMP commercialization for one of our clients.

This is a diverse and challenging role with key accountabilities including :

  • Providing Quality Input on the life cycle of Validation documents from URS’s through to PQ’s
  • Implementing QA on the shop floor; reviewing sterilization cycles, FMS systems and cleanroom logbooks
  • Providing quality and compliance input in reviewing of Batch Manufacturing Record Reviews, CAPA’s & Deviations, Complaints & OOS across departments.
  • Review and update of Standard Operating Procedures and Controlled Documents as required.
  • Working closely with the site Qualified Persons (QPs) ensuring batch release schedules are adhered to.
  • Closure of batch records with associate LIMS & SAP transactions & C of A generation.
  • Local area & local system audits.
  • Media fill observation, reading & report writing
  • Providing annual product reviews for our client’s product.
  • Participation in investigating customer complaints.
  • Cleanroom opening support (requalification of equipment & services).
  • Experience

    You will be a flexible, highly motivated and experience Quality professional seeking a new opportunity to develop and grow your skills within a unique operating model.

    To be considered for this role you will have experience of the Pharmaceutical industry and a strong understanding of current GMP and technical processes.

    In addition to this we are looking for an individual who is able to demonstrate

  • Minimum Science based degree.
  • Proven industry experience in a Quality Assurance Pharmaceutical manufacturing environment.
  • A working knowledge and practical experience with GMP guidelines.
  • Experience of working in a sterile manufacturing facility would be advantageous.
  • Involvement in the set-up of a new facility or process would be useful.
  • Prior experience with regulatory bodies such as FDA and MHRA is highly desirable.
  • Prior experience with Cephalosporin’s would also be an advantage.
  • Closing date for applications : 3rd Feb 2019

    When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.

    The information that you have provided in your cover letter and CV will be used to assess your application.

    Thank you for your interest in this opportunity.

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