To lead, plan and execute qualification and validation operations, including new analytical methods, new analytical equipment, fa.....
To lead, plan and execute qualification and validation operations, including new analytical methods, new analytical equipment, facilities, and computerised systems within Newcastle Specials to enable new product development and ensure GMP compliance. To ensure the principles of EudraLex Volume 4, Part 1, GMP Annex 15: Qualification and Validation, are applied in the above activities. To ensure all aspects associated with the Validation Protocols are based on Quality Risk Management and compliant with the local Pharmaceutical Quality System. To ensure all Validation protocols are prepared, approved and implemented in accordance with GMP Annex 15 (Qualification and Validation) and Annex 11 (Computerised systems). The relevant concepts and guidance in ICH Q8, Q9, Q10, Q11 and Q12 should also be taken into account. To maintain the Validation Master Plan for maintenance of current equipment and facilities and also managing the introduction of new equipment and processes, co-ordinating quality and production departments to enable timely implementation 1. Identify Critical Quality Attributes for new equipment and processes 2. design and author validation protocols 3. co-ordinate implementation of validation protocols and assessment and management of risks and control strategy 4. Reviewing of completed validation protocols for acceptance of rejection To project manage and ensure that targets for validation protocols are formally and consistently reported at Quality Review Group (QRG) meetings using relevant tools such as GANTT charts to identify milestones and identify and highlight areas that may introduce delay, also any corrective/preventive actions that have been required and documented effectively, including confirmation that actions have been undertaken to maintain target timeframes. To train Newcastle Specials Pharmacy Production & Quality Control staff and others as required (either directly or indirectly) regarding regulatory requirements during new validation processes and implementation. To attend Regulatory audits and provide support and direction during the hosting of such audits as necessary with respect to Validation activities. To assist the Trust Quality Controller in the implementation of a harmonised validation approach within the Pharmaceutical Quality System. To design systems and protocols in a manner to optimise the utilisation of Newcastle Specials personnel time and facilities, identifying opportunities for process efficiencies and leading on their implementation. To evaluate and implement new equipment and technologies to improve capability or efficiency within Newcastle Specials. To deliver a comprehensive and responsive validation service to the RVI and Freeman sites. (Includes Clinical trial manufacture, Licensed Sterile and Non-sterile Manufacturing and Homecare Services) To undertake a key leadership role within the organisation, being visible and working closely with quality assurance, quality control managers, pharmacy business manager, senior production staff, and clinical trials team to lead validation processes. Creates URS (User requirement specifications) to reflect current regulatory requirements when looking to source equipment and/or services understand their requirements, defining project plans to ensure timely delivery of manufacturing and analytical requirements. Lead in the development, implementation and monitoring of validation practices through knowledge of National and local policies, protocols and guidelines. Prepare reports as required to demonstrate new product development progress and process improvement outcomes to increase portfolio of high-quality pharmaceutical products for the needs of our patients and customers. Work closely with the Trust Quality Controller to manage the validation processes. Leads on safe introduction of equipment and systems defined unlicensed preparation and /or licensed manufacturing sections across two Trust sites, maintaining safe systems in accordance with Health & Safety and COSHH regulations. As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you. Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate. The method of payment is a salary deduction from your first months pay.
