Quality Assurance Specialist

JR United Kingdom; Leicester; On-site; GBP 35,000 - 55,000; Full time

Job summary

A leading company is seeking a motivated Quality Specialist to join their Global Development Quality team. This role involves ensuring compliance with GMP in reviewing clinical batch records and approving data packs for Qualified Person release. The ideal candidate will have a scientific background and strong attention to detail.

Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmacy or similar.
• Strong attention to detail and organizational skills are essential.
• Excellent communication and interpersonal abilities are crucial.

Responsibilities

• Perform final review of clinical batch records for compliance.
• Compile and approve data packs for Qualified Person release.
• Collaborate with global supply chain teams and manage issue resolution.

Skills

Attention to detail

Organizational skills

Communication

Interpersonal abilities

Education

Bachelor’s degree in a scientific discipline

Job description

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.

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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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Created on 04/06/2025 by JR United Kingdom