Senior Validation Specialist
2 weeks ago
Job summary
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.
Main duties of the job
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
About us
The Advanced Therapies Manufacturing Unit (ATU) is co-located with the Clinical Research Facility (CRF) at Guy's Hospital on the 15th floor of the tower. The ATU is purpose built for the manufacture of Advanced Therapy Medicinal Products such as somatic cell therapies, gene therapies and tissue engineered products for early-phase clinical trials or as Specials. It is used for both commercial and non-commercial collaborators as well as departments within GSTFT and KCL to manufacture ATMPs related to trials undertaken in the CRF and at trial sites across the UK.
Job description
Job responsibilities
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 completionEnsure 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.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.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.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 Units 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.
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.
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. Person Specification
Qualifications/ Education
Essential
BSc degree in cell biology or equivalent Evidence of courses and ongoing specialist training for GMP and validation activities Track record of clinical or medical research
Desirable
Has undertaken research in Immunology, Haematology or equivalent experience Registered Pharmacist with the General Pharmaceutical Council (GPhC)
Experience
Essential
Postgraduate or equivalent specialist experience in quality assurance activities in a regulated environment Expert knowledge and hands on experience of Good Manufacturing Practice (GMP) or JACIE standards. Specialist knowledge with equipment and software validation for GMP and JACIE accreditation Excellent troubleshooting and data presentation skills Ability to organise resources and planning Expert in controlled documentation and record keeping as well as generation of SOPs
Desirable
Experience with ISBT 128 labelling systems
Skills/Knowledge
Essential
Ability to work independently Ability to participate in the organisation of the GMP unit Ability to communicate complex ideas verbally and in writing. Ability to work collaboratively and as part of a team
Desirable
Specialist knowledge of deviation management within a pharmaceutical quality system Experience in training staff and students-
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