Pharmaceutical Quality Assurance Officer

3 weeks ago

London, Greater London, United Kingdom Guys and St Thomas NHS Foundation Trust Full time
Pharmaceutical Quality Assurance Officer


We are seeking a dedicated and skilled quality assurance professional to enhance our Quality Team at Guys and St Thomas'.

Ideal candidates will possess experience in the pharmaceutical sector or NHS quality assurance roles.


The selected individual will collaborate with our licensed units, making experience in unlicensed areas essential.


This position offers an exceptional opportunity for healthcare scientists who have completed the STP programme and are currently engaged in foundational quality roles.


Joining our team allows you to leverage your GMP and Quality expertise, preparing you for advanced roles involving project leadership and personnel management.


The QA department encompasses diverse areas across the hospital trust, providing a chance to engage with various teams across multiple disciplines.


This role lays a solid foundation for candidates aspiring to advance in Quality Assurance, with opportunities to work alongside seasoned quality professionals.


  • Lead and deliver Pharmaceutical QA Services to the Trust Pharmacy Manufacturing and Quality Control Units.
  • Maintain integrated Quality Systems across the Pharmacy Manufacturing Service in accordance with relevant licenses and NHS guidelines.
  • Act as a Releasing Officer for unlicensed products received into the Trust.
  • Provide technical support and QA advice to other departments and external clients.


Guy's and St Thomas' is one of the UK's most prominent NHS Foundation Trusts, offering a comprehensive range of hospital and community services.


Our Technical Services division operates a large licensed manufacturing unit with a diverse product portfolio, including terminally sterilized, aseptically manufactured, and non-sterile products.


Pharmacy Quality Assurance extends support to various facilities across both sites, including licensed and unlicensed units.


Service Management
  • Ensure the pharmaceutical quality management system is upheld and developed per licensing requirements and regulatory changes.
  • Provide senior QA input into complex quality exceptions, ensuring satisfactory corrective and preventative actions.
  • Communicate changes to the quality management system effectively across all staff levels.
  • Conduct Trust GMP Internal Audits and ensure timely reporting and actioning of audit findings.
  • Maintain and develop documentation control systems in line with GMP standards.

Personnel Management, Training, and Development
  • Supervise the Technical / Clinical Interface Pharmacists and QA Officers to ensure compliance with current legislation.
  • Ensure all QA department staff are adequately trained and competency assessed.
  • Participate in the recruitment and selection process for QA department staff.

Service Evaluation and Development
  • Critically assess current quality management systems to promote continuous improvement.
  • Attend regulatory and internal audits, leading responses to audit deficiencies.

Clinical Trials
  • Review new trials requiring QA services to ensure compliance with regulations.
  • Assess quality requirements for new clinical trials under the Section 10 exemption.

Research and Development
  • Provide QA support for the development and validation of new products.

Clinical Services
  • Offer expert pharmaceutical QA advice on unlicensed products.
  • Respond to MHRA Drug Alerts and coordinate stock retrieval and replacement.

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