Senior QA Specialist GMP Regulations

2 weeks ago


Glasgow, Glasgow City, United Kingdom CV-Library Full time

About the Role

The successful candidate will be responsible for providing QA input to various activities and ensuring compliance with Good Manufacturing Practice (GMP) regulations.

About Our Client

Our client, CDM Life Sciences, is an emerging immunotherapy company developing innovative treatments for cancer and severe viral infections.

Key Responsibilities

  • Review and approve batch manufacturing data sets in accordance with procedures for GMP.
  • Provide general support to all Quality unit activities relating to GMP, GCP, and other Quality Systems.
  • Conduct audits and reviews of GMP validation reports, protocols, and reports to ensure accuracy and consistency.
  • Prepare for MHRA/FDA and other regulatory body audits.
  • Perform data integrity audits/checks for GMP, GCP, and non-GxP data.
  • Develop and implement Quality Management Systems and training programs.

Qualifications and Experience

  • Bachelor's degree in a science discipline or equivalent experience in a GMP regulated company.
  • Strong knowledge of GMP regulatory requirements and quality management principles.

Estimated Salary: £31,750 per annum based on location and industry standards.



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