Quality Systems Specialist

7 days ago


Birmingham, Birmingham, United Kingdom University Hospitals Birmingham NHS Foundation Trust Full time

**Job Overview:**

We are seeking a highly skilled Quality Systems Specialist to join our team at University Hospitals Birmingham NHS Foundation Trust. The successful candidate will have extensive experience in developing and implementing quality systems to ensure compliance with cGMP and MHRA requirements.

The ideal candidate will have substantial experience in preparing evidence portfolios for NHSLA, CQC, and MHRA standards, as well as expertise in leading on the preparation for external audits by MHRA or Regional Quality Assurance.

**Key Responsibilities:

  1. Develop and implement quality systems to ensure compliance with cGMP and MHRA requirements.
  2. Authorise all systems of work and documentation in the aseptic units, radio pharmacy, and other licensed areas.
  3. Ensure ongoing adherence to quality systems through regular internal inspections and reporting.

**Requirements:

  • MSc Pharmaceutical Technology and Quality Assurance or equivalent qualification.
  • Eligibility for Qualified Person Status under European Statutory Directive 2001/83/EC Article 51.
  • Extensive experience in developing and implementing quality systems, with expertise in preparing evidence portfolios.

**Salary:** £80,000 - £100,000 per annum, depending on experience.



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