Pharmacy Quality Assurance Manager inChesterfield inChesterfield PUBLISHED FRI 22 NOV 2024

We are pleased to offer an exciting secondment opportunity for the role of Quality Assurance (QA) Manager for pharmacy at Chesterfield Royal Hospital.

Pharmacy Aseptic Services prepare and dispense aseptically prepared SACT and MAB treatments for patients at CRH. There are 2 licensed aseptic suites within the trust.

We are looking for a highly motivated candidate with an attention to detail, excellent organisational skills and the ability to work to tight timescales. Also need to be a great team player and have exceptionally strong interpersonal and communication skills.

The successful candidate will manage the QA team and work closely with Pharmacy Managers to develop QA Services, providing and maintaining a safe efficient pharmaceutical service to wards and departments across the Trust.

If you have a passion to provide an excellent, patient focused pharmacy service within a busy but friendly department, we would encourage you to apply.

Provide leadership and delivery of Pharmaceutical Quality Assurance services to the Trust. Including but not limited to:

Patient specific manufacture of ready to administer products, including systemic anti-cancer treatment (SACT) and high-risk injectables , for the Trust.

Aseptic dispensing of systemic anti-cancer medicines (SACT), and high-risk injectables.

Senior line management to all Quality Assurance (QA) staff

To be named on the Trust's Manufacturing Licence as the Trust's Head of Quality.

Authorisation of all systems of work and documentation in the aseptic units, and other licensed areas

Oversee the design, implementation and maintenance of the Pharmaceutical Quality Systems (PQS) ensuring requirements of cGMP and consequently the MHRA are met.

Ensure adherence to the PQS through appropriate training and motivation of pharmacy production and QA staff.

Ensure continuing adherence to the requirements of PQS and cGMP through regular internal inspections and report compliance via the Pharmacy Governance.

About us

• To establish, develop and monitor the quality systems applicable to the pharmacy service with a particular focus on those relating to Manufacturing, Wholesale Dealing, Dispensary and other registered activity
• To review and approve quality documentation and systems including change management, GMP / GDP deviations, recalls, complaints, product defects etc.
• To undertake and support the preparation of SOP
• To ensure satisfactory maintenance and monitoring of the aseptic manufacturing unit and equipment
• To lead and co-ordinate internal quality audits (Production Unit and Stores and distribution) and external audits as required
• To ensure that appropriate validations are carried out including production and QC processes and that the resultant reports are written and distributed
• To approve written, or amended master worksheets, which relate to or might impinge upon licensable activities
• To set up technical agreements for outsourced service e.g. domestic services in compliance with GMP and QAAPS standards
• Responsible for organising regular QA/Production, QA/WDA and QA/Dispensary meetings to maintain Quality Assurance within the pharmacy and to monitor progress against internal and external inspections
• To be responsible for the internal procedures and policies relating to the release and rejection of materials by the Releasing Officers
• As a releasing officer, responsible for the approval or rejection of raw materials, intermediates, hospital manufactured, commercial products and packaging materials and to keep appropriate records, including maintaining electronic records.
• To be responsible for the approval or rejection of purchased unlicensed pharmaceuticals and for writing assessments for approval of suppliers.
• To evaluate Pharmacy manufacturing batch records, alongside Quality Control reports, prior to release or rejection of a batch
• To be responsible for the review and reporting of all microbiological testing results provided by Quality Control including consultations and discussions of action plans with the Production Manager if results are outside of recommended guidelines
• To embed quality risk management principles in all processes and documentation. This includes performing risk assessment in line with regulatory standards e.g. ICH, PIC/S, GMP
• To write, assess and evaluate tender specifications for services and equipment.
• To monitor outsourced services and escalate any deficiencies
• Ensure that key GMP records such as the site master file, validation master plan, control strategies and the quality manual is kept up to date and meets the needs of service users, in conjunction with regulatory, licensing and accreditation bodies.
• To support and where indicated lead investigations into deviations in quality processes
• To contribute to external inspection requirements relating to GMP and GDP eg MHRA , CQC , GPhC
• Ensure appropriate escalation of all risks and outstanding corrective and preventative actions
• Coordinate the investigation of relevant complaints in accordance with the complaints policy and procedure, in conjunction with service. Promote the provision of a customer centred approach in the provision of pharmacy services Liaise with service users through forums and surveys to establish views and opinions that will help to improve service standards.
• Provide monthly performance reports to the Pharmacy Quality Management Committee and Management Board
• Maintain relevant records, ensuring accurate data input into all computerised systems.
• To validate computerised systems (licensed activity only) to meet regulatory compliance
• Maintain an archive of all controlled documents in accordance with the data integrity requirements of regulatory, licensing and accreditation bodies, and in compliance with corporate policy and national legislation and guidance.
• Collect, interpret and present quality management data and statistics for use in monitoring the quality management system.
• Ensure robust systems are in place to develop staff, to ensure they can carry out their work safely and efficiently, working to the high standards demanded of the service, and providing evidence of competence assessment
• To manage the work of the Senior Pharmacy QA officer , ensuring that task are delegated appropriately
• Training
• To prepare and present tutorials and training sessions, both within the department, and externally as required
• To be responsible for the competency checks of Releasing officers and production staff and assessment prior to signing off training records
• To ensure that the Continuing Professional Development needs of the releasing officers are met
• To act as a mentor for Principal Department Leads across Pharmacy
• Monitor the review of training competences across the relevant parts of the pharmacy service, promptly reporting deficiencies to service managers as appropriate.
• Educate and train staff in quality principles and practice.
• Ensure that staff are adequately trained to understand and use the quality management system as relevant to their roles, and that training and competences are suitably documented and reviewed

• To assist in the design and provision of necessary commissioning of new production facilities and equipment
• To offer QA expertise and resources to other departments as required by the Trust
• To be responsible for the development and validation of new processes and methods in Quality Assurance and in the Production facilities.
• To maintain procedures and implement changes resulting from the updating of GMP and other regulatory standards and guidance documents
• To ensure the implementation of national and regional policies within Pharmacy
• To be named as the responsible person for Quality Control (Quality Controller) on regulatory MHRA manufacturers licenses as appropriate
• To be the Quality Control representative for Wholesale Dealing Activities.
• To represent Pharmacy Technical Service at CRH NHS Foundation Trust at internal development/management meetings, external regional meetings (East Midlands Technical Services Meetings) and nationally (National QA Symposium).
• Follow up on external inspections and verify the completion of corrective action as required by the inspectors reports in collaboration with service managers
• To contribute to the implementation of Quality Governance within the pharmacy service.
• To provide QA support into the operation of Clinical Trials in the department.