Quality Assurance Officer

An exciting and challenging opportunity has arisen for a QA Officer within a leading Contract Development and GMP Manufacturing Organisation in the ever-evolving field of Biologics and Regenerative Medicine.

This Edinburgh-based company operates at the leading edge of therapeutic discovery providing services for companies involved in European and US clinical trials.

Reporting to the Head of QA, this role will provide support for the Quality department within the company and will assist with the busy ongoing GMP QA activities on a day to day basis.

The company work to the highest standards of quality and customer service and the individual taking up this post must share these values and be able to demonstrate excellent customer service skills for both internal and external customers as well as experience within a GMP Quality Department.

Specific Responsibilities

  • Reviewing and approving Incident Reports, Change Controls and Risk Assessments
  • Performing data review audits (Batch Production Records, Validation Documents and Development Documentation as required)
  • Supporting the operation with Validation activities
  • Reviewing Standard Operating Procedures (SOPs) to ensure compliance with GMP and other relevant regulatory requirements
  • Performing internal audits to determine compliance with GMP and identify areas for improvement.
  • Issuing and reviewing Corrective and Preventative Actions (CA/PAs).
  • Reviewing and approving suppliers / service providers including audit of critical suppliers where required.
  • Supporting the QA Manager with hosting customer audits.
  • Providing advice and guidance to the wider team with support from the QA Manager.
  • Supporting the administration of the company’s documents management system.

Skills/Experience Required:

The successful candidate will have:

  • An honours degree in a life science subject or equivalent qualification.
  • Experience within a GMP Quality Department is essential
  • Experience in using Document Management systems would be desirable
  • Must have a good working knowledge of GMP clean rooms operating at a Grade A/B level.
  • Excellent data recording and record keeping skills with a good eye for detail