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Pharmaceutical Quality Assurance Specialist

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. Quality System Management: Maintain the integrated Quality Systems across the Pharmacy Manufacturing Service as required by the MS, MA(IMP) licences and NHS guidance.
  2. Releasing Officer: Act as a Releasing Officer for any unlicensed products received into the Trust as required.
  3. Technical Support: Provide technical support and advice on QA to other departments in the Trust and to external customers of the Trust.
  4. Quality Management System Development: 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.
  5. Quality Exceptions: Provide senior QA input into complex quality exceptions to ensure satisfactory corrective and preventative action is taken.
  6. Internal Audits: Carry out Trust GMP Internal Audits.
  7. Microbiological Testing: Coordinate the documentation, sample collection and results reporting for the microbiological testing service.
  8. Customer Complaints: Respond to customer complaints and undertake drug defect investigation for Trust manufactured products.
  9. Drug Alerts: Coordinate the Trust response to Drug Alerts issued by the MHRA.
Personnel Management, Training and Development
  1. Supervision: Supervise the work of the Technical / Clinical Interface Pharmacists (Band 7) and QA Officers B6/7.
  2. Staff Training: Ensure that all staff working in the QA department are trained and competency assessed in the tasks they undertake.
  3. Training and Development: 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. Quality Improvement: Critically assess the current quality management systems with a view to maintaining a continuous quality improvement cycle within the department.
  2. Regulatory Compliance: Attend regulatory and internal audits and meet the requirements of the auditor in a clear and concise manner.
Clinical Trials
  1. QA Review: 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: 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: Provide QA support to the development, formulation and validation of new products in response to clinical need and risk management.
Clinical Services
  1. Expert Advice: Provide expert pharmaceutical QA advice on the use of all other products prepared by the Unlicensed Units.
  2. Unlicensed Medicines: Assess the suitability of unlicensed medicines purchased by the Trust and release for use as appropriate.