Quality Assurance Senior Associate

Key responsibilities:

  • Provide supporting day-to-day operation of the Quality Assurance department
    • Operate in accordance to GMP
    • Review and process deviations and change controls
    • Conduct internal and external audits (UK and EU)
    • Collate and review manufacturing and testing records
    • Allocate unique identifier reference numbers to documents
    • Issue and publish documents
    • Archive documents
    • Track and trend compliance paperwork (deviations, change controls, both internal and external)
    • Author and review deviations
    • Author and review Corrective and Preventative actions
    • Populate QMS metrics
    • Manage and store all Milton Park staff training records
    • Provide support to all Replimune internal and external customers
  • Adhere to company documentation policies and maintaining documentation systems as required.

Preferred Educational requirements:

  • A minimum of a degree.

Experience and skill requirement:

  • A highly motivated individual, with excellent time management
  • A very organised and methodical approach to tasks
  • IT skills – competent in using Microsoft Office.
  • An interest in pharmaceutical Quality Assurance
  • A level of flexibility is essential to meet varying workloads.
     

Hours of work

  • 37.5 hours per week of five days Monday to Friday inclusive. The company operates a flexible working arrangement between the hours of 8am - 6pm.

Salary

  • £25K - £34K      + pension scheme, optional BUPA membership and other staff benefits

More information

Applicants should be highly organised and committed, have at least five years of experience within a GMP environment.  Quality Assurance experience is essential.  Fluency in the French language is beneficial  It is an expectation that the successful candidate will develop their Quality Assurance skills and experience to further support Replimune business as well as individual personal development.

Please send your CV to Chris.Kerley@Replimune.com