Quality Assurance Specialist

JR United Kingdom; Newcastle upon Tyne; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Quality Assurance Specialist to join its Global Development Quality team in Newcastle upon Tyne. The role involves reviewing clinical batch records, collaborating with supply chain teams, and ensuring regulatory compliance, providing a crucial contribution to life-saving treatments.

Qualifications

• BSc in a relevant scientific discipline.
• Strong attention to detail and organizational skills required.
• Excellent communication and interpersonal abilities needed.

Responsibilities

• Perform final review of clinical batch records for compliance.
• Compile and approve data packs for QP release.
• Collaborate with global clinical supply chain teams.

Skills

Attention to detail

Organizational skills

Communication

Interpersonal abilities

Ability to work independently

Education

Bachelor’s degree in Chemistry, Biology, Pharmacy

Job description

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Quality Assurance Specialist, newcastle-upon-tyne, tyne and wear

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Client:

Planet Pharma

Location:

newcastle-upon-tyne, tyne and wear, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

2

Posted:

04.06.2025

Expiry Date:

19.07.2025

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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.

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.