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Pharmacy Quality Officer

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent

On-site

GBP 30,000 - 40,000

Full time

3 days ago
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Job summary

A renowned healthcare institution in the United Kingdom is seeking a Quality Assurance professional to support its Pharmacy Quality Management Systems. The ideal candidate will have extensive experience in Pharmaceutical Quality Management and be responsible for ensuring compliance with regulatory guidelines while improving the quality processes within a busy pharmacy unit. Excellent organizational and communication skills, alongside a detail-oriented approach, are necessary. This role offers an opportunity for growth and development in a pivotal department.

Qualifications

  • Extensive experience in Pharmaceutical Quality Management systems.
  • Ability to work independently or as part of a team.
  • Organisational skills and attention to detail are crucial.

Responsibilities

  • Assist in the operation of the Pharmacy Quality Management Systems.
  • Ensure compliance with MHRA Manufacturer's 'Specials' Licence.
  • Support routine environmental monitoring of cleanroom facilities.
  • Develop performance dashboards for pharmacy technical services.

Skills

Pharmaceutical Quality Management systems
Excellent organisational skills
Communication skills
Digital skills
Attention to detail
Teamwork
Job description
Overview

The MHRA licensed 'Specials' pharmacy manufacturing unit is based at the Royal Stoke University Hospital and is a modern purpose-built unit within the hospital. The service encompasses the manufacture of sterile products, and the production of over‑labeling and re‑packaging products, supplying both the trust and external organisations. The quality team are responsible for ensuring compliance with MHRA rules and guidelines and also supporting the manufacturing activities within the Pharmacy Technical services production team and the Radiopharmacy service at UHNM.

Responsibilities
  • Assist in the operation, maintenance and development of the Pharmacy Quality Management Systems (PQMS) meeting the changing requirements of the department, the Trust and external regulators.
  • Assist in ensuring compliance with the terms of the Medicines and Healthcare Products Regulatory Authority (MHRA) Manufacturer's 'Specials' Licence, ICH and other national guidelines related to pharmaceutical manufacturing and reconstitution or repackaging activities.
  • Support PQMS including electronic and paper-based documentation systems ensuring compliance to the requirements of MHRA GxP data Integrity.
  • Support the routine environmental monitoring of cleanroom facilities.
  • Support the future development of the Pharmacy Services delivered to patients across the organisation, in line with the Directorate Business Plan and the Trust Vision and Strategic Objectives.
  • Monitor Key Performance Indicators and support the development of performance dashboards for pharmacy technical services.
  • Participate in appropriate rotas, including weekend and bank holiday working.
Qualifications
  • Extensive and recent experience of Pharmaceutical Quality Management systems, e.g., change control, deviation investigations, and CAPA management.
  • Band 5 role requires this experience; band 4 may be offered to applicants with little or no experience, with robust objectives to progress to band 5 within 2 years.
  • Excellent organisational, communication and digital skills, high attention to detail, independence and the ability to work on own or as part of a team.
Equal Opportunity

We are committed to equality of opportunity and welcome applications from everyone regardless of ethnicity, disability, gender, age, faith or sexual orientation. Appointment will be based on merit alone.

Flexible working will be considered in line with Trust policies.

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