Senior QP: Batch Release & QMS Lead

AssureBio

Manchester

On-site

GBP 70,000 - 100,000

Full time

13 days ago
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Job summary

AssureBio is seeking an experienced Qualified Person (QP) to join their quality function in the UK. The role combines hands-on batch release with a leadership stake in the site's QMS.

This is an on-site, full-time role based in Manchester, offering scope to broaden responsibilities beyond release. You will review batch records and analytical data, lead investigations into deviations, support regulatory audits, and guide internal teams on quality standards while contributing to ongoing QMS

Qualifications

  • A science degree in chemistry, pharmacy, biology or related field.
  • Eligible QP (UK) status.
  • Minimum 3 years' hands-on testing experience of active substances and medicinal products.
  • QP release experience in sterile manufacturing, radiopharmaceutical or nuclear medicine is advantageous.
  • Some experience managing a QMS or a Quality team.

Responsibilities

  • Batch release of medicinal products with full regulatory compliance.
  • Review and sign-off of batch records, analytical data and supporting documentation.
  • Lead investigations into deviations and quality issues.
  • Represent Quality at internal and regulatory audits.
  • Advise internal teams on regulatory and quality standards.
  • Contribute to ongoing QMS development and management.

Skills

QP release
QMS management
Regulatory compliance
Audits

Education

Science degree
Eligible QP (UK)

Job description

AssureBio is seeking an experienced Qualified Person (QP) to join their quality function in the UK. The role combines hands-on batch release with a leadership stake in the site's QMS.

This is an on-site, full-time role based in Manchester, offering scope to broaden responsibilities beyond release. You will review batch records and analytical data, lead investigations into deviations, support regulatory audits, and guide internal teams on quality standards while contributing to ongoing QMS

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