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Quality Assurance Specialist

JR United Kingdom

Dartford

On-site

GBP 30,000 - 45,000

Full time

3 days ago
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Job summary

A leading global development quality team is seeking a motivated Quality Specialist to ensure compliance with GMP standards and regulatory requirements. This role involves reviewing clinical batch records and collaborating with manufacturing sites, driving accuracy and compliance in the delivery of life-saving treatments.

Qualifications

  • Bachelor’s degree in a scientific discipline required.
  • Strong attention to detail is essential.
  • Experience in QA or GMP environment is preferred.

Responsibilities

  • Perform final review of clinical batch records for compliance.
  • Compile data packs for Qualified Person (QP) release.
  • Collaborate with global clinical supply chain teams.

Skills

Attention to detail
Organizational skills
Communication
Interpersonal abilities

Education

Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy)

Job description

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An exciting opportunity is available for a motivated and detail-oriented Quality Specialist to join a Global Development Quality team. This role offers exposure to a wide range of investigational medicinal products, from small molecules to advanced immunotherapies, contributing directly to the delivery of life-saving treatments to patients.

Key Responsibilities:

  • Perform final review of clinical batch records to ensure compliance with GMP and regulatory filings.
  • Compile and approve data packs for Qualified Person (QP) release.
  • Collaborate with global clinical supply chain teams and manufacturing sites (internal and external).
  • Manage issue resolution and ensure timely documentation and communication.
  • Maintain high standards of accuracy and compliance throughout the review process.

Qualifications & Skills:

Required:

  • Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy).
  • Strong attention to detail and organizational skills.
  • Excellent communication and interpersonal abilities.
  • Ability to work independently and manage multiple priorities.

Preferred:

  • Prior experience in a QA or GMP-regulated environment.
  • Familiarity with clinical manufacturing and regulatory compliance processes.
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