Sterile Product Quality Specialist

22 hours ago


Bathgate, West Lothian, United Kingdom Disability Solutions Full time
Company Overview
Catalent, a global leader in drug development and delivery, is seeking a highly skilled Sterile Product Quality Specialist. With over 7,000 life-saving and life-enhancing products being developed and delivered annually, our team plays a crucial role in ensuring the quality and safety of these medicines.

Job Summary
We are looking for a qualified professional to provide QA expertise, ensure quality processes operate to acceptable standards, and certify finished products prior to release for clinical study. As a Sterile Product Quality Specialist, you will participate in the management team investigating and performing product recalls, and contribute to the continuous improvement of quality processes.

Responsibilities
  • Provide QA expertise to ensure quality processes operate to acceptable standards.
  • Certify finished products prior to release for clinical study.
  • Review and approve GMP documents where required.
  • Liaise with technical and other quality organisations within Catalent and their clients to investigate and generate recommended improvements for batch release.
  • Participate in the management team investigating and performing product recalls.

Requirements
  • Sterile and Biological Product experience.
  • Experience of Biotech Products.
  • ATMP product experience preferred but not essential.
  • Qualified person in accordance with Directive SI 2012/1916 and/or SI 2004/1031.
  • BSc or equivalent in a relevant scientific discipline, eg Chemistry or Biology.
  • Demonstrable experience and sound knowledge of GMP regulations.
  • Competence in both written and verbal communication.
  • Ability to interact with personnel at all levels from a variety of disciplines.

What We Offer
  • An estimated salary of £60,000 - £80,000 per annum.
  • A hybrid working arrangement that allows for flexibility and work-life balance.
  • Pension scheme and life assurance.
  • Healthcare insurance and disability solutions.


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