Deputy Quality Assurance Manager: Aseptic Services
| Dyddiad hysbysebu: | 30 Gorffennaf 2025 |
|---|---|
| Cyflog: | £72,921.00 i £83,362.00 bob blwyddyn |
| Gwybodaeth ychwanegol am y cyflog: | £72921.00 - £83362.00 a year |
| Oriau: | Llawn Amser |
| Dyddiad cau: | 17 Awst 2025 |
| Lleoliad: | London, SE1 9RT |
| Cwmni: | NHS Jobs |
| Math o swydd: | Parhaol |
| Cyfeirnod swydd: | C9196-25-1375 |
Crynodeb
Professional Leadership To support and assist the Head of Pharmaceutical Quality in the efficient and effective running of the Quality Assurance function. To demonstrate expert technical knowledge and advanced level of clinical technical reasoning and judgement. To be recognized as a national expert within Quality Assurance Policy and Planning To develop Pharmaceutical Quality Systems to meet the changing needs and demands of the Trust and of external Regulators (eg: MHRA and Regional Quality Assurance) To contribute to the planning and design of new and upgraded pharmaceutical manufacturing, preparation and dispensing facilities within the Trust To develop, write and present business cases for equipment, staff resources and service developments within the Pharmaceutical QA Services function To advise the Head of Pharmaceutical Quality and Senior Pharmacy staff in the determination of policy and plans for pharmaceutical services To lead on the risk assessment and documentation of major changes to be made to Pharmacy Technical Services. Personnel Management, Training and Development To manage QA staff, including objective setting, appraisals, performance and attendance monitoring To be responsible for recruitment of staff to QA and QC Services, including advertising, short-listing, interviewing and selecting staff To develop training programmes for QA staff to ensure GMP and GLP compliance of Quality Services To undertake and manage Trust HR procedures in respect of discipline, grievances and sickness absence To participate in the training of pharmacists, scientists, pre-registration pharmacy graduates, technicians, and student pharmacy technicians as required Resource Management To support the purchase of new and replacement equipment. To help define the specifications, sourcing, price negotiation, installation, maintenance and repair of such equipment To be responsible for the purchase of consumables for Quality Assurance. Research and Development To undertake, supervise and give guidance on research projects arising from the work of technical services. To publish research and development work To participate in investigations into the formulae used in the Production Unit, and into the determination of stability and shelf life To undertake and support the development, formulation and validation of new products in response to clinical need and risk management in accordance with objectives set by the Head of Pharmaceutical Quality. To be responsible for QA advice and support necessary for the management of Clinical Trials in the Pharmacy in accordance with the statutory requirements for Good Clinical Practice Quality Assurance To establish, monitor and review QA Standard Operating Procedures To monitor, review and approve, specifications for starting materials, finished products, packaging materials which have been prepared by the Quality Control Department To monitor, review and approve manufacturing documents and Standard Operating Procedures which have been prepared by the Production Units To manage the provision of a quality assurance service to various GSTT units and external bodies. To monitor, review and approve analytical methods for carrying out tests and analyses, both physico-chemical and microbiological To develop and manage Technical Agreements for the provision of services to GSTT by external companies To act as lead Releasing Officer for components, starting materials and finished products used by or prepared with the Trust To examine components, starting materials and finished products for compliance with specifications and to release or reject each batch as appropriate To manage and coordinate the response to the remote temperature monitoring system across the Pharmacy department To generate Certificates of Analysis on request to support the supply of manufactured medicines to external customers of the Trust Pharmaceutical Quality System Management To critically evaluate the Pharmaceutical Quality Systems across all areas to ensure that compliance with regulatory requirements is maintained. Through local huddles and other meetings work with the Accountable Pharmacists to review Pharmaceutical Quality System metrics and escalate deficiencies in resources and other key issues to the Head of Pharmaceutical Quality and Associate and Chief Pharmacists Working with the Accountable Pharmacists monitor capacity within all Pharmacy Technical Services areas to maintain the Pharmaceutical Quality System and report Pharmaceutical Quality System performance at management review meetings To develop and maintain an effective Deviation Reporting system within Pharmacy Technical Services. To be responsible for ensuring that Deviations are fully investigated as to Root Causes and to approve proposed corrective and preventive actions To develop and maintain a document control system as part of the Pharmaceutical Quality System, in line with GMP and MHRA requirements To provide documented evidence/reports to demonstrate that the Pharmaceutical Quality System is performing to the required standards Audit To oversee the internal audit programme for the aseptic units and ensure this is maintained and appropriate to the level of risk of each unit To undertake internal audits and document and review internal audit reports as directed by the Head of Pharmaceutical Quality To provide Internal Audit reports to Senior Management on a regular basis To provide regulatory audit progress reports to the MHRA, Regional QA and Senior Management as required To represent Quality Assurance at regulatory audits and meet the requirements of the auditor in a clear and concise manner. To lead on the response to audit deficiencies and ensure these are carried out in a timely manner Facilities Monitoring To ensure monitoring takes place in accordance with GMP To provide training to all staff in the techniques used to monitor the manufacturing environment. To manage the recording, documentation and review of environmental monitoring results To manage the Deviation reporting system for environmental monitoring and implement corrective/preventative actions in a timely manner To manage the maintenance of results databases, review and provide reports on trended data on a regular basis To develop, maintain and review external contracts with companies providing a pharmaceutical microbiological testing service. Product Safety To investigate and report on medicine defects, arising from both commercial and GSTT-made products, liaising with the Region and Regulatory Authorities as appropriate To co-ordinate actions within the Trust on drug recalls To provide the QA advisory role in the Trusts purchase of medicines To advise the Trust on the use of unlicensed medicines To assess the quality of unlicensed medicines supplied from outside the Trust and provide recommendations as to their suitability for use within the Trust Validation To provide specialist knowledge and advice to senior technical staff on validation requirements for new equipment, facilities and processes To manage the commissioning and validation of new pharmaceutical Manufacturing/QC built within the Trust To approve Technical Agreements made with external contractors for the (re)validation of equipment, facilities and processes To review periodic equipment, facility and process (re)validations to ensure compliance with Technical Agreements in place and the appropriateness of results. To manage any Deviations thrown up by the (re)validations To liaise with the Lifecycle Manager to ensure the key objectives within the validation master plan for Technical Services are met. Regional Liaison To participate in regional training initiatives for manufacturing, preparation, dispensing and quality assurance To deputise as a member of the Regional Quality Assurance Group To be a member of other regional groups as required by the Regional Quality Assurance Pharmacist, Head of Pharmaceutical Quality or Chief Pharmacist To undertake the collection and collation of information relating to Quality Assurance by arrangement with the Regional Quality Assurance Pharmacist Other Duties To undertake other reasonable duties as requested by the Head of Pharmaceutical Quality, Chief Pharmacist or the Regional Quality Assurance Pharmacist To at all times practise in accordance with the Code of Ethics of the General Pharmaceutical Council, whether registered with the GPhC or not To take personal responsibility for promoting a safe environment and safe patient care by identifying areas of risk and following the Patient Safety Incident Reporting Framework policy and procedure.