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.

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.