Band 8b Quality Assurance Specialist

5 months ago

Hampstead, United Kingdom Royal Free London NHS Foundation Trust Full time

QA/QC Specialist - Quality Assurance Specialist

Band 8b

The Pharmacy department of the Royal Free London NHS Trust is a friendly, progressive, and expanding unit dedicated to providing the highest standards of pharmaceutical care and service in this large, internationally renowned teaching hospital. The Trust has good transport links to the West End and major mainline train stations such as Kings Cross, Euston, Stratford, London Bridge and Charing Cross.

We are seeking an experienced QA specialist to join the team to maintain and develop the QA service provided to the licensed unit at the Royal Free Hampstead site and also the unlicensed unit at Barnet Hospital.

The Royal Free Hospital Pharmacy Manufacturing Unit supplies high quality bespoke products to both Primary and Secondary Care and Research organisations.

The facility has a MHRA Manufacturer “Specials” Licence (MS), a Wholesale Distribution Authorisation (WDA(H)) and a Manufacturer Licence for Investigational Medicinal Products (Clinical Trials) (MIA(IMP)).

The post holder will be actively involved in Clinical Trial services provided by the Pharmacy departments.

We have expanded as a Trust to include the Barnet and Chase Farm hospital sites making us one of the largest NHS Trusts in the UK. In addition to this, we have an expanding and high-profile clinical trials unit which forms part of the Institute of Immunity and Transplantation based on the Hampstead site of the Trust.

On the Hampstead site we also host one of the most extensive manufacturing suites in the NHS.

1. RESPONSIBILITY FOR POLICY AND SERVICE DEVELOPMENT
- To deliver the key targets for the Trust research and development agenda as agreed between the post holder and the Head of Pharmaceutical Quality
- To ensure the pharmaceutical quality management system is maintained and developed in accordance with the ML (specials) and MA (IMP) license requirements and in response to changes in regulations and legislation.
- To ensure Trust GMP Internal Audit Programme and audits are reported and actioned in a timely manner.
- To ensure QA requirement for validation master plan are fully completed and documented
- To assist in the review of service contracts and technical agreements with suppliers.
- To assist in the review and update of QA/QC procedures.
- To assist in the review and update of specifications for raw materials, finished products, packaging materials and labels.
- To assist in the review, update and approval of manufacturing documents and procedures.
- To establish and implement procedures for environmental monitoring in the Pharmacy Production and preparation areas and to maintain records of the monitoring completed.
- To act as a Quality Controller for piped medical gases adhering to the requirements of HTM02 and assist in providing medical Gas Testing service across the sites
- To assist in the qualification, commissioning and validation of new facilities and equipment.
- To assist in the approval of standard operation procedures within the Pharmacy Production and QA/QC units.
- To contribute to the formulation of patient specific medicines in response to the individuals clinical needs.
- To undertake GMP audits of external suppliers as required.
- To assist in maintaining the Quality Management System used by all Trust licenced facilities. This involves effective management of non-compliance reviews, implementation and management of agreed action plans, advice and technical input into investigations and quality risk management issues.
- To assist in the effective management of the Change Control and Unusual Events programme ensuring improvements and any regulatory changes are assessed and implemented.
- To assist in the development and management of a robust document control system as an integrated part of the Quality system according to GCP and MHRA requirements.
- To establish and implement procedures for the department wide temperature monitoring system in the medicine storage areas which includes but not limited to pharmacy production and preparation areas, dispensary areas, stores and clinical trial areas and review record of alarms generated.
- To respond to customer complaint and investigate and report on defective medicines for Trust manufactured products.
- To coordinate the trust response to Drug Alerts issued by the MHRA.

2. Staff Supervision and Training

To train and supervise the work of the laboratory technical staff to undertake method development and ensure that activities undertaken meet current legislative guidelines such as GMP/GDP. GCP, Health and safety, COSSH.
To assist in managing staff assigned to the QA/QC Department including objective setting, performance and attendance monitoring
To participate in the training of pharmacists, chemists, pre-registration pharmacy graduates, technicians and student technicians with the QA department and external to the trust as necessary.
To complete appraisals for junior QA/QC staff as requested by the H

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