Senior Validation Specialist

The Trust is committed to obtaining JACIE accreditation to permit the safe delivery of Advanced Therapies including Immune Effector therapies. One of the requirements of JACIE is to comply with ISBT 128 labelling of medicinal products of human origin. This position has been newly created to enable the purchase, delivery and validation of both hardware and software components of a selected ISBT128 labelling system.
Working under the Advanced therapy Pharmaceutical Quality System, the post holder will use their specialist knowledge in Good Manufacturing Practice (GMP) to maintain compliance with regulatory standards when implementing and validating the new system.
The job will include review and oversight of activities undertaken by the supplier of the labelling system and ensure full oversight of completion of the vendors documentation. In addition to the generation of validation documents to completed the IOQ of the labelling system and ultimately end user SOPs and training package., + Work within the Advanced Therapies GMP unit and implement the change control to onboard a new ISBT128 labelling system
+ Take professional responsibility for specialist validation of the ISBT 128 labelling system, including completion of installation qualification and operational qualification
+ Develop label templates that are JACIE compliant and produce validation documentation to qualify the labels
+ Generate an end user SOP for the use and maintenance of the labelling system and be in a position to develop a training package and deliver training on the system, + Work within the Advanced Therapies GMP unit and implement the change control to onboard a new ISBT128 labelling system
+ Work across cross functional teams to ensure the user requirement specifications of the required labelling system are met and the correct system is purchased and delivered to the unit
+ Take professional responsibility for specialist validation of the ISBT 128 labelling system, including completion of installation qualification and operational qualification
+ Review and approve any vendor supplied documentation prior to completion
· Ensure good documentation practice is adhered to by the vendor of the system and external GMP personnel when completing documentation
· Develop label templates that are JACIE compliant and produce validation documentation to qualify the labels
· Generate an end user SOP for the use and maintenance of the labelling system and be in a position to develop a training package and deliver training on the system
+ Capable of working independently and as part of a team of clinicians, scientists and regulatory personnel. An ability to provide and receive complex scientific information is required, as is the ability to make concise and accurate input to regulatory submissions. Therefore, you will have good organizational and communication skills with proven record of scientific achievements.
4.2 Management and Leadership Responsibilities
+ Be able to familiarise themselves with JACIE labelling requirement and understand the labelling requirements for different departments including GMP Annex 13 requirements.
+ Lead on and integrate the ISB128 labelling system to cover labelling of different Trust activities and support JACIE accreditation for the Trust.
+ Plan and prioritise the specialist quality assurance service workload, liaising with other departments, and suppliers in relation to the labelling system.
+ Work unsupervised managing any validation deviations, making informed decisions relating to quality systems. You will independently undertake specialist Validation and Qualification of the labelling suytem for the GMP Unit as delegated by the Head of Advanced Therapy Quality.
+ Provide day-to-day professional supervision of any vendor validation and qualification of the system and provide end user training for production and quality control activities.
4.3 Quality Assurance Process Responsibilities:
+ Using specialist experience in Good Manufacturing Practice and the standards for the Quality and Safety of Tissues and Cells for Human Application you will become familiar with production and analytical methods involving closed cell processing, primary cell culture, immunomagnetic depletion (MACS), FACS and expansion methods.
+ Work collaboratively with internal departments to support JACIE accreditation of the Trust and support with the development of any JACIE SOPs that are required for the GMP unit.
+ You will lead on any integrating any planned preventative maintenance required for the hardware and software of the labelling system into the current Validation Master Plan.
+ Computer competency in quality management software is essential. Be able to communicate effectively with the IT department to implement the software system into the Trust.
+ Be involved with the prepaprtion of JACIE accreditation and be able to represent the GMP unit during any inspections.
4.4 Documentation Responsibilities:
Using your specialist knowledge you will undertake the development and generation of:
+ Unit-specific SOPs and policies relating to quality assurance operations and labelling of starting material and final products. These must comply with GMP and the Unit's manufacturing licence.
+ Update Product Specification Files or with new ISBT128 label templates.
· Undertake documentation control procedures, using database systems to track GMP documentation. You will work autonomously to Standard Operating Procedures and protocols.
4.6 Information Management Responsibilities
· Work in compliance with national standards for the safe, secure and confidential processing and storage of patient and laboratory information and when accessing patient information on computer databases.
· You will be active interpreting data, and participate in writings for publication.
· Responsible for the maintenance and use of a GMP laboratory database; you will use software to create specialist reports where required.
4.7 Working Conditions:
The role calls for a detail-orientated and highly-motivated individual with the ability maintain and develop quality management systems.
+ Prolonged concentration is required when reviewing records and undertaking audits.
+ There will be prolonged work in a clean room, with careful movements and behaviour within a Grade D GMP environment, and the continued use of clean room Personal Protective Equipment.
Guy's and St Thomas' celebrates, respects and values the diversity of its staff and patients. We review our policies, procedures and practices to ensure that all employees, patients and carers are treated equitable according to their needs. We are actively committed to ensuring that no one who applies for a job, works or study's at the Trust, or accesses our services is discriminated against on the grounds of race, ethnicity, nationality, disability, religion or belief, age, gender identity , gender reassignment, sexual orientation, pregnancy and maternity/paternity, or marital/civil partnership.
Applications are welcomed from applicants with a disability. We can make reasonable adjustments and offer support and advice in a variety of ways throughout the application process. Equality of opportunity is our policy.
As an organisation we are committed to developing our services in ways that best suit the needs of our patients. This means that some staff groups will increasingly be asked to work a more flexible shift pattern so that we can offer services in the evenings or at weekends.
Flexible working
We are committed to supporting all employees to achieve a healthy work life balance and to work in a way that is best for them and our patients. We will consider all requests to work flexibly, taking in to account the individual's personal circumstances as well the needs of the service. We encourage all prospective applicants to discuss their individual circumstances with the recruiting manager as part of the on-boarding process.
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Guy's and St Thomas' is among the UK's busiest and most successful NHS foundation trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopaedic, respiratory and cardiovascular services.
Guy's is home to the largest dental school in Europe and a £160 million Cancer Centre opened in 2016. As part of our commitment to provide care closer to home, in 2017 we also opened a cancer centre and a kidney treatment centre at Queen Mary's Hospital in Sidcup. St Thomas' has one of the largest critical care units in the UK and one of the busiest emergency departments in London. It is also home to Evelina London Children's Hospital.
Evelina London cares for local children in Lambeth and Southwark and provides specialist services across south east England including cardiac, renal and critical care services. We lead a number of specialist service networks aiming to ensure children are treated locally where possible, but have access to specialist expertise when they need it. Our community services include health visiting, school nursing and support for families of children with long-term conditions.
Our adult community services teams deliver care at the heart of the local communities we serve, working in partnership with GPs, local authorities and other healthcare and voluntary sector organisations. Working with our partners in Lambeth and Southwark, we are focusing on new ways of working to improve care for local patients.
In February 2021 the Royal Brompton and Harefield joined Guy's and St Thomas' NHS Foundation Trust, bringing together world-leading expertise in the care and research of heart and lung disease. Our merger provides a once in a generation opportunity to build a lasting, world-renowned heart and lung centre, providing the highest quality care for patients and conducting world-leading research.
We have a reputation for clinical excellence and high quality teaching and research. We are part of King's Health Partners, one of eight accredited UK academic health sciences centres. In partnership with King's College London we have dedicated clinical research facilities including an MHRA accredited Phase I clinical trials unit.
Patients are at the heart of everything we do and we pride ourselves on ensuring the best possible patient experience as well as safe, high quality care. We are proud to have one of the lowest mortality rates in the NHS. Following a comprehensive Care Quality Commission (CQC) inspection in 2019 we maintained our overall rating of 'good'. Our adult community services achieved a rating of 'outstanding'.
The commitment of our 23,500 staff is key to our success. We are one of the largest local employers and we aim to develop and support all our staff so they are able to deliver high quality, safe and efficient care. The 2019 NHS staff survey results show that we have one of the most engaged and motivated workforces in the NHS. We know this has a positive impact on the care provided to our patients.
We have one of the most ambitious capital investment programmes anywhere in the NHS.