Total 2 Manager level Quality Assurance / Control job vacancies in YOKOHAMA 02

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.

[What the role is]

MANAGER / DEPUTY MANAGER, IT SYSTEMS (TEST & QUALITY ASSURANCE)

[What you will be working on]

To align with the Digital Government Blueprint’s vision of “Digital to the Core, and Serves with Heart”, LTA is embarking on a digital transformation journey by harnessing new technologies to drive broader efforts to revamp the digital platform, develop and integrate enterprise-wide IT systems. We envision to leverage cloud services such as government commercial cloud infrastructure for enhanced business agility and build stakeholder-centric services that cater to businesses’ needs.
You will be responsible for quality assurance through carefully curated testing standards, methodologies and automations for the development of applications across legacy and new systems for the transformation and modernisation of applications.
You will be involved in:
•Collaborating with business analysts, technical architects, application and integration leads, frontend and backend development teams to understand the requirements, identify key areas of testing required across application, infrastructure and security domains and implement testing activities to address the testing needs of these areas
•Defining overall testing strategy to ensure that IT systems meet required quality standards. This includes test frameworks, test methodologies, test planning, test team management, test execution, test automation, stakeholder communication etc.
•Developing test plans, test scenarios, test scripts, test conditions, test data and test cases with expected results for tests such as integration, interfaces, user story acceptance, regression, smoke, system, performance, deployment and user acceptance tests.
•Managing all aspects of the testing efforts, including plans, interdependencies, schedule and tools etc. required
•Creating and building high quality, maintainable, and performant code for automated test cases identified and the frameworks to execute and report them
•Ensuring that defect tracking (identification, fixing, re-testing) is properly addressed and all testing results are easily accessible and understandable.
•Reviewing test results to ensure that they meet the acceptance criteria, work with development team to resolve any issues that arise out of the testing process and report the test status to stakeholders involved

[What we are looking for]

•Tertiary qualification in Computer Science/Engineering or any relevant qualification with at least 5 years’ IT experience in IT systems delivery and testing
•Experience in software engineering / enterprise architecture across multiple products, systems and platforms coupled with strong business acumen experience in solutions design and enterprise architecture delivering IT solutions for both legacy and modern applications
•Strong understanding of testing concepts and how testing fits in with the overall project life cycle. Ability to develop and manage all aspects of the testing effort.
•Knowledge of the continuous integration environment with automated testing components implemented
•Knowledge in IT automation tools IT infrastructure and applications and automated testing concepts for web development
•Ability to review project deliverables for completeness, quality, and compliance with established project standards.
•Able to document and follow detailed instructions within test scripts as well as defects tracking documents (i.e., steps to recreate the problem)
•Ability to document and communicate the status of testing progress against plans, taking corrective action as necessary
•Ability to define, implement, and maintain project process guidance related to testing
•Ability to consult with and develop technical resources for methods, procedures, and standards to use during testing