QA Validation Manager

An exciting opportunity has arisen for a highly motivated individual to join the Quality Assurance Team at Newcastle Specials in the role of QA Validation Manager. This new post will lead the validation of both analytical methods, analytical equipment and computerized systems in accordance with Pharmaceutical Good Manufacturing Practice Guidelines (GMP). You will work closely with the production and business teams to ensure we deliver projects and products for our customers, client and service users.
You will have a thorough understanding of GMP, a strong technical background and be an excellent communicator and experience of project delivery.
+ Interview Date Monday, 14 October 2024
+ 37 Hours 30 Minutes/Week
+ You will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy

Main duties of the job
With excellent communication and organisational skills, you will lead implementation, development and planning of all stages of the validation lifecycle for analytical methods, analytical equipment and computerised systems. You will review and agree method validation strategy for any outsourced activity.
Using your knowledge of GMP you will ensure a risk based approach to validation in accordance with our validation master plan is executed. You will be involved in creation of URSs for new equipment, evaluation of tenders, agreement and execution of qualification protocols.
Using GANTT charts/other tools you will project manage, reporting on progress against target, identify milestones and areas that may introduce delay and strategies to overcome.
You will train Quality Control staff and others as required (either directly or indirectly) regarding GMP, GDP, QA and regulatory requirements during new analytical method or equipment qualification and implementation., + 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 month's pay.
Important note on completion of reference section of Application Form
All references from current and previous employers will be sought and must cover a minimum of 3 years employment. Therefore, when completing the reference section of your application form, please give the address, telephone number and work email address of each of your current/previous line managers that cover 3 years employment. Failure to complete this section may result in your application not being processed.
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 month's pay.
Candidates who are shortlisted for interview will be contacted by e-mail. You should check your SPAM folders as well as your inbox. If you have not been contacted within 4 weeks of the closing date you should assume your application has been unsuccessful.

Newcastle Hospitals NHS Foundation Trust is one of the busiest, largest and most successful teaching NHS foundation trusts in the country, with around 16,000 staff and an annual income of £1 billion.
We have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally.
We're also proud to be the second largest provider of specialised services in the country. This means we support people with a range of rare and complex medical, surgical and neurological conditions, cancers and genetic orders.
Our staff oversee around 1.84 million patients 'contacts' each year, delivering high standards of healthcare.
We are committed to promoting equality and diversity and recognise the benefit in providing an inclusive environment. We value and respect the diversity of our employees and aim to recruit a workforce which reflects the communities we serve, and is equipped to deliver the best service to our patients. We welcome all applications irrespective of people's race, disability, gender, sexual orientation, religion or belief, age, gender identity, marriage and civil partnership, pregnancy and maternity and in particular those from under- represented groups.
Newcastle Hospitals are proud to be one of the exemplar organisations across the NHS on sustainability, with a long history of delivering Sustainable Healthcare in Newcastle (Shine) and the first healthcare organisation in the world to declare a climate emergency. Our strategy includes commitments to being Net Zero by 2030, for our direct carbon footprint, and Net Zero by 2040 for our footprint plus. Delivering these ambitions will not be possible without the help, support and action of every single member of our team., Newcastle Hospitals NHS Foundation Trust is one of the busiest, largest and most successful teaching NHS foundation trusts in the country, with around 16,000 staff and an annual income of £1 billion.
We have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally.
We're also proud to be the second largest provider of specialised services in the country. This means we support people with a range of rare and complex medical, surgical and neurological conditions, cancers and genetic orders.
Our staff oversee around 2 million patients 'contacts' each year, delivering high standards of healthcare.
Please see attached information on what Staff Benefits we have to offer at our Trust.
We are committed to promoting equality and diversity and recognise the benefit in providing an inclusive environment. We value and respect the diversity of our employees and aim to recruit a workforce which reflects the communities we serve, and is equipped to deliver the best service to our patients. We welcome all applications irrespective of people's race, disability, gender, sexual orientation, religion or belief, age, gender identity, marriage and civil partnership, pregnancy and maternity and in particular those from under- represented groups.