Senior Validation Specialist

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 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 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.

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.

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

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

Guy's and St Thomas' NHS Foundation Trust

Address

Guy's Hospital

Great Maze Pond

London

SE1 9RT

Employer's website

https://www.guysandstthomas.nhs.uk/careers/careers.aspx (Opens in a new tab)