Quality Assurance Manager

6 days ago

London, Greater London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full time
About the Role

We are seeking an experienced Pharmaceutical Quality Assurance Specialist to join our team at Guy's and St Thomas' NHS Foundation Trust. As a key member of our Quality Assurance department, you will play a crucial role in ensuring the highest standards of quality and compliance in our pharmaceutical manufacturing and quality control units.

Key Responsibilities
  • Quality Management System
    • Develop and maintain the integrated Quality Management System across the Pharmacy Manufacturing Service, ensuring compliance with MS, MA(IMP) licences, and NHS guidance.
    • Act as a Releasing Officer for unlicensed products received into the Trust, ensuring adherence to regulatory requirements.
  • Technical Support and Advice
    • Provide technical support and advice on Quality Assurance to other departments within the Trust and external customers.
  • Service Evaluation and Development
    • Critically assess the current Quality Management System to maintain a continuous quality improvement cycle within the department.
    • Update and enhance current unit documentation in line with accepted guidelines and changes in the workings of the QA department.
  • Clinical Trials
    • Review new trials requiring QA services to ensure compliance with The Medicines for Human Use (Clinical Trial) Regulations 2004.
    • Review and authorise all clinical trial production documentation to ensure preparation of clinical trials complies with all regulator requirements.
  • Research and Development
    • Provide QA support to the development, formulation, and validation of new products in response to clinical need and risk management.
Person Specification
  • Qualifications
    • Pharmacy degree or Masters degree in a science-based discipline.
    • Post-graduate qualification relevant to pharmaceutical manufacturing or a portfolio demonstrating equivalent specialist pharmaceutical knowledge.
  • Experience
    • Previous evaluated experience working as a Releasing Officer in a licensed/unlicensed pharmaceutical production unit with a comprehensive portfolio of products.
    • Experience of quality systems and documentation management systems.
  • Skills
    • Demonstrated practical knowledge of GMP, QA, risk management, and all current relevant regulations.
    • Demonstrated ability to identify and manage risks.
    • Demonstrated ability to undertake the day-to-day management, motivation, and appraisal of staff.
What We Offer

As a Pharmaceutical Quality Assurance Specialist at Guy's and St Thomas' NHS Foundation Trust, you will have the opportunity to work in a dynamic and challenging environment, contributing to the delivery of high-quality patient care. You will be part of a team that is committed to excellence and continuous improvement, and you will have access to a range of training and development opportunities to support your career growth.

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