Qualified Person

Ipsen Biopharm Ltd

Wrexham, United Kingdom
Fully onsite
Certify and release finished product batches
Eligible to act as qualified person uk/eu
Strong working knowledge of gmp requirements
Ipsen Biopharm Ltd is seeking a Qualified Person for their Wrexham site, focusing on ensuring compliance with UK and EU regulatory requirements for medicinal products. The role emphasizes leadership in quality assurance and requires significant pharmaceutical industry experience

Job Summary

  • The role involves certifying and releasing finished product batches in full compliance with EU/UK regulatory requirements.
  • Ipsen Wrexham is a highly invested site with recent £24m investment and further expansion underway.
  • Candidates will act as a subject matter expert during regulatory inspections and mentor the Quality Operations team.

Matching Summary

Match Score: 85

Ipsen Biopharm Ltd is seeking a Qualified Person for their Wrexham site, focusing on ensuring compliance with UK and EU regulatory requirements for medicinal products. The role emphasizes leadership in quality assurance and requires significant pharmaceutical industry experience.

Skills & Requirements

Must-have

  • Certify and release finished product batches
  • Eligible to act as Qualified Person UK/EU
  • Strong working knowledge of GMP requirements
  • Fluent written and spoken English
  • Degree in relevant scientific discipline

Nice-to-have

  • Previous experience on IMP licence
  • Lean Six Sigma continuous improvement qualifications
  • Lead Auditor qualification
  • Sterile manufacturing expertise
  • Collaborative mindset across functions

Key Requirements

  • Qualified Person eligibility under UK/EU regulations
  • Significant pharmaceutical industry experience
  • Degree in Chemistry, Pharmacy, Biology, or Biochemistry

Work Rights

Must be eligible to act as a Qualified Person under UK/EU regulations

Tailored Resume

Cover Letter