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GMP Quality Specialist

2 months ago

London, Greater London, United Kingdom Planet Pharma Full time
Job Title: GMP Quality Specialist

Company: Global Leading Pharmaceutical Company

Contract Duration: 6 months contract with a high chance of extension and potential for permanent employment

FTE: Full-time (37.5 hours/week)

Location: Hybrid working arrangement near Bank, London

Company Overview

Our client is a global healthcare leader dedicated to improving health and well-being worldwide. With a presence in over 140 countries, they focus on developing and delivering innovative medicines, vaccines, and healthcare solutions. This global presence offers a diverse working environment that encourages collaboration across borders, providing employees with exposure to international projects and opportunities for global career advancement.

Role Summary

This role provides an excellent opportunity for an experienced QA professional to join the Global Development Quality group as a Contract Quality Specialist. The position offers exposure to a wide range of investigational medicinal products in our development pipeline, from simple small molecules to complex immunotherapy treatments. The ideal candidate will be proactive, able to work independently, and possess a meticulous eye for detail, contributing to the release of critical investigational products.

Key Responsibilities:

  • Conducting the final review of clinical batch records to ensure compliance with GMP standards and adherence to regulatory filings.
  • Compiling and approving data packs for presentation to the Qualified Person (QP) for final release.
  • Collaborating closely with global teams supporting the clinical supply chain and both internal and external clinical manufacturing sites worldwide.
  • Managing issue resolution efficiently while ensuring high standards of communication and attention to detail.

Required Experience, Knowledge & Skills:

  • Previous experience in a QA or similar role within a GMP environment is highly desirable.
  • New science graduates with a Bachelor's degree and a strong willingness to learn are also encouraged to apply.
  • Excellent communication skills and the ability to manage tasks with minimal supervision are essential.