Quality Assurance Officer at Replimune, Inc.
London, London - England, United Kingdom -
Full Time


Start Date

Immediate

Expiry Date

29 Jan, 27

Salary

40000.0

Posted On

31 Oct, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Yes

Skills

Industry

Hospitals & Health Systems

Description
  • What you'll be doingSupporting the QA Officer in reviewing procedures and completed batch paperwork, covering both manufacturing and analytical documentation
  • Reviewing manufacturing, laboratory and associated documentation ahead of QP review and final product disposition, and flagging potential issues early
  • Reviewing and approving documentation for incoming raw materials and updating SAP
  • Generating and checking product and status labels
  • Providing line clearance to support manufacturing activities
  • Acting as the QA point of contact for SAP and material/component clearance, escalating issues to the QA Team Leader or QA Manager where needed
  • Identifying and escalating any cGMP issues that could affect batch quality
  • Checking QMS records for closure and keeping departmental systems up to date
  • You'll work with colleagues in QC, Compliance and Production, as well as customers and suppliers. This is a varied role with real visibility across the site.


  • What we're looking forA BSc in a relevant scientific discipline (or equivalent)
  • A minimum of 3 years' experience in a cGMP environment manufacturing Active Pharmaceutical Ingredients (APIs)
  • Experience working with QA, analytical chemistry, development and manufacturing teams (beneficial)
  • Excellent attention to detail
  • Strong written and verbal communication skills
  • Good organisation and the ability to prioritise your workload to meet deadlines
  • The ability to analyse data, identify root causes and make considered decisions
  • A team player who can also work confidently on your own initiative
  • The confidence to follow instructions accurately and escalate issues when needed
  • Flexibility to work a shift pattern, including weekends


Responsibilities
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