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.

About us

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.

Job description

Job responsibilities

• 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.

Person Specification

Qualifications & Education

Essential

• Masters level qualification or equivalent qualification or equivalent experience in a relevant discipline
• Relevant experience of working in a licensed pharmaceutical facility
• Audit of services by external auditing organisation e.g. MHRA
• Managing or training staff
• Extensive theoretical and practical experience of audit and policy development in a range of settings to Masters level or equivalent
• Proven experience in a GMP environment and/or quality setting, including policy developments
• Ability to work strategically

Desirable

• Policy design and implementation
• Trained in appraisal skills
• Degree with a scientific background
• Experience of quality management systems and methodologies
• Experience of preparing for external inspection
• Experience of monitoring compliance with national risk management/quality standards

Knowledge & Experience

Essential

• Knowledge of Pharmaceutical Audits e.g. MHRA
• Knowledge of Good Manufacturing Practice (Rules & Guidance for Pharmaceutical Manufacturers and Distributors)
• Knowledge of a Validation Master Plan within a pharmaceutical Quality System
• Application of health and safety and COSHH in pharmaceutical setting
• Experience of providing training
• Experience of executing validation protocols
• Knowledge of EU GMP Annex 15: Qualification and Validation
• Knowledge of EU GMP Annex 11: Computerised systems
• Knowledge of Quality Risk management approach to qualification and validation activities (ICH Q9)

Desirable

• Working knowledge of sterilisers for pharmaceutical applications
• Working knowledge of WFI systems
• Working knowledge of designs of various isolators types
• Experience of performing Validation protocols within a pharmaceutical GMP environment
• Experience of preparing validation documents within a Pharmaceutical GMP environment
• Experience of cleaning validation/verification
• Working knowledge of validation master plans and their application
• Working knowledge of QC analytical equipment and method validation

Skills & Abilities

Essential

• Excellent interpersonal and communication skills
• Organisation and planning skills
• Leadership and management skills
• Negotiation, persuasion and problem-solving skills
• Project management skills and knowledge
• Research and audit skills
• Broad IT skills
• Service improvement/change management skills
• Well-developed report writing and analytical and presentation skills
• Evidence of relevant continuous professional development
• Ability to lead meetings
• Counselling / mentoring
• Ability to manage change and meet deadlines
• Excellent communication skills
• Ability to collaborate effectively with cross-functional teams
• Strong attention to detail

Desirable

• Interviewing / appraisal
• Effective staff management skills

Employer details

Employer name

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Address

Royal Victoria Infirmary

317 02 Royal Victoria Infirmary

NE1 4LP

Any attachments will be accessible after you click to apply.

317-2024-32-028