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Quality Assurance Manager

2 months ago

London, Greater London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full time
Job Summary

We are seeking an experienced Pharmaceutical Quality Assurance Specialist to join our Quality Team at Guy's and St Thomas' NHS Foundation Trust. The successful candidate will be responsible for leading and delivering Pharmaceutical QA Services to the Trust Pharmacy Manufacturing and Quality Control Units.

Key Responsibilities
  1. Lead and Deliver Pharmaceutical QA Services: The successful candidate will be responsible for leading and delivering Pharmaceutical QA Services to the Trust Pharmacy Manufacturing and Quality Control Units.
  2. Maintain Integrated Quality Systems: The candidate will be responsible for maintaining the integrated Quality Systems across the Pharmacy Manufacturing Service as required by the MS, MA(IMP) licences and NHS guidance.
  3. Act as Releasing Officer: The candidate will act as a Releasing Officer for any unlicensed products received into the Trust as required.
  4. Provide Technical Support: The candidate will provide technical support and advice on QA to other departments in the Trust and to external customers of the Trust.
  5. Ensure Pharmaceutical Quality Management System: The candidate will ensure that the pharmaceutical quality management system is maintained and developed in accordance with the MS and MA(IMP) licence requirements and in response to changes in regulations and legislation.
  6. Senior QA Input: The candidate will provide senior QA input into complex quality exceptions to ensure satisfactory corrective and preventative action is taken.
  7. Trust GMP Internal Audits: The candidate will carry out Trust GMP Internal Audits.
  8. Microbiological Testing Service: The candidate will coordinate the documentation, sample collection and results reporting for the microbiological testing service.
  9. Customer Complaints: The candidate will respond to customer complaints and undertake drug defect investigation for Trust manufactured products.
  10. Drug Alerts: The candidate will coordinate the Trust response to Drug Alerts issued by the MHRA.
Personnel Management, Training and Development
  1. Supervise Technical/Clinical Interface Pharmacists: The candidate will supervise the work of the Technical/Clinical Interface Pharmacists (Band 7) and QA Officers B6/7.
  2. Staff Training and Competency: The candidate will ensure that all staff working in the QA department are trained and competency assessed in the tasks they undertake.
  3. Training of Pharmacists, Technicians and Scientists: The candidate will participate in the training of pharmacists, technicians, and scientists with the QA department and externally to the trust as necessary.
Service Evaluation and Development
  1. Continuous Quality Improvement: The candidate will critically assess the current quality management systems with a view to maintaining a continuous quality improvement cycle within the department.
  2. Regulatory and Internal Audits: The candidate will attend regulatory and internal audits and meet the requirements of the auditor in a clear and concise manner.
Clinical Trials
  1. Review of New Trials: The candidate will review new trials requiring QA services to ensure that the protocol, authorisation and ethical approval meets the requirements of The Medicines for Human Use (Clinical Trial) Regulations 2004.
  2. Quality Requirements for Clinical Trials: The candidate will review new trial documentation and assess the quality requirements for new clinical trials to be made under the Section 10 exemption.
Research and Development
  1. QA Support to Product Development: The candidate will provide QA support to the development, formulation and validation of new products in response to clinical need and risk management.
Clinical Services
  1. Expert Pharmaceutical QA Advice: The candidate will provide expert pharmaceutical QA advice on the use of all other products prepared by the Unlicensed Units.
  2. Assessment of Unlicensed Medicines: The candidate will assess the suitability of unlicensed medicines purchased by the Trust and release for use as appropriate.