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Quality Assurance Manager

2 months ago

London, Greater London, United Kingdom Imperial College Healthcare NHS Trust Full time
About the Role

We are seeking a highly skilled Quality Assurance Manager to join our team at Imperial College Healthcare NHS Trust. As a key member of our quality team, you will play a critical role in maintaining compliance with all relevant licensing and accreditation standards for our site.

Key Responsibilities
  • Work closely with the Head of Quality to maintain compliance with all relevant licensing and accreditation standards for the site.
  • Improve service delivery to users by working in partnership with all stakeholders.
  • Day-to-day involvement with colleagues of varying levels of seniority in many departments and centres regarding all elements of the Quality system.
  • Deputising for the Head of Quality and assist the cross-function teams when required.
  • Producing reports and leading quality review meetings with department managers.
  • Facilitating meetings to investigate events and determine root cause.
  • Organising and managing the workload for the quality function.
  • Maintaining and keeping up to date with standards of Good Manufacturing Practice.
  • Participating in the training and development of permanent and temporary staff working in the unit.
  • Supporting the maintenance and management of the programmes JACIE accreditation.
  • Undertaking risk assessments, COSHH assessments, and the GAP assessment of new process/product introduction.
About Us

At Imperial College Healthcare NHS Trust, you will have the opportunity to work with leading clinicians pushing boundaries in patient care. Our team is committed to delivering high-quality care and services to our patients, and we are looking for a skilled Quality Assurance Manager to join us in this mission.

Requirements
  • Education to BSc level in Biomedical Science degree or equivalent.
  • Experience working to Good Manufacturing Practice (Industry or NHS).
  • Experience in problem-solving, deviations, root cause analysis, corrective and preventive actions.
  • Experience in documentation, record management, and data integrity.
  • Experience in conducting and reporting internal audits.
Desirable Qualifications and Experience
  • Experience in managing an electronic quality management system Q-Pulse.
  • Experience working in MHRA licensed facilities.
  • Experience with Advanced therapy medicinal products (ATMPs).
  • Experience in technology transfer.
Skills and Knowledge
  • Good understanding of JACIE & HTA standards and their application.
  • Understanding EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines and application.
  • Knowledge of ICH Guidelines.