We are seeking a dynamic and experienced Lead Quality Assurance Professional to join our Aseptic Services Team in Pharmacy. This role is critical to ensuring the delivery of high-quality pharmaceutical services, focusing on the areas of Quality Assurance (QA), Quality Control (QC), and Validation. The post is open to qualified Technicians and Pharmacists with relevant experience and offers a pathway to career progression from Band 7 to Band 8a based on demonstrated capabilities and leadership.
Key Responsibilities:
1. Lead the development, implementation, and maintenance of Quality Management Systems (QMS) within the department, ensuring compliance with NHS and regulatory standards (e.g. GMP, GPhC).
2. Conduct audits to monitor and maintain quality standards, identifying areas for improvement and ensuring action plans are developed and implemented.
3. Oversee the QC processes within the department, ensuring that products, services, and procedures meet required specifications and standards.
4. Provide expert advice on product testing and quality analysis, reviewing QC results and ensuring corrective actions are taken when necessary.
5. Lead the validation of processes, equipment, and systems in accordance with national and local standards.
6. Develop and execute validation protocols, ensuring that all aspects of validation are documented and performed to regulatory requirements.
7. Provide leadership to the Aseptic Services Team, fostering a culture of quality and safety within the department.
8. Provide line management and support to other members of staff within the team.
9. Ensure a robust change control procedure is in place and when required present any change management documentation to Pharmacy and Trust stakeholders and the Pharmacy Risk and Governance Group.
10. Responsible for the capacity planning of the Aseptics Team in which the plan is routinely reviewed with recommendations of improvement expected by the Principal Pharmacist to ensure the continued optimised operation of the Aseptic Unit.
11. Ensure all maintenance works within the Aseptic Unit are carried out in a timely manner according to the Planned Preventative Maintenance (PPM) schedule and liaise with the Estates Department and relevant contractors.
12. Manage and maintain service level agreements and contracts with partners and suppliers.
13. Develop and review the Aseptic contingency plan ensuring that all areas of operation have a suitable business continuity plan inclusive but not limited to paper, digital systems and the Aseptic Unit.
14. Be responsible for frequent testing of the Aseptic contingency plan ensuring all areas remain fit for purpose.
This advert closes on Friday 11 Apr 2025.
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