Job overview
An excellent opportunity has presented itself at Great Ormond Street Hospital Trust, Zayed Centre for Research into Rare Disease in Children (ZCR) for a Quality Assurance Senior Education and Training Officer in our Cell and Gene Therapy Service (C>S). We are proud of being part of a well renowned national centre of excellence in the provision of specialist children's health care, currently delivering the widest range of specialist care of any children's hospital in the UK.
The C>S manufactures life-saving therapies for paediatric patients under MHRA licence. We are expecting to soon manufacture within our new state of the art, purpose-built facility (ZCR), comprising of seven cGMP compliant laboratories and support services. Our manufacturing facilities are licensed by the MHRA to allow us to function within the terms of our MIA(IMP) and MS licences.
The Quality Assurance Senior Education and Training Officer postholder will be supporting the activities of Quality Assurance (QA) by following internal standard operating procedures, Good Manufacturing Practice (GMP) principles, and regulatory guidance. The post holder will have a significant focus on the maintenance of the training programme for the Cell and Gene Therapy Service (C>S) facility.
The postholder as a member of the Quality team will work closely with the Production and manufacturing teams to build quality into the department, support staff in their training needs and ensure work is carried out in accordance with local, national and professional standards and regulatory guidelines.
Main duties of the job
The postholder will be working within the regulatory and legal frameworks to support maintenance and improvement of the established training programmes within C>S through support and coordinate training activities, provide routine GMP induction and refresher trainings and carry out spot checks to ensure compliance.
Support the Quality Assurance function help build quality culture by supporting Core/Production and NGGO teams in designing and building quality into the facility management and manufacturing activities; support the development of key documentations and management of quality records and assist in the maintenance of the Quality Management Systems (QMS).
Working for our organisation
GOSH is committed to recruiting the best person for the job, based solely on their ability and individual merit as measured against the criteria for the role; through a process that is fair, open, consistent and free from bias and discrimination.
We are committed to being a diverse and inclusive employer and foster a culture where all staff are valued, respected and acknowledged. All applicants will receive consideration for employment without regard to race, colour, national origin, religion, sexual orientation, gender, gender identity, age, disability status or length of time spent unemployed.
We particularly welcome applications from BAME communities, people with disabilities and/or long-term health conditions and LGBT+ community members.
We have policies and procedures in place to ensure that all applicants and employees are treated fairly and consistently. We are proud to be accredited as a Disability Confident Employer, a member of Business Disability Forum and a Stonewall Diversity Champion.
We have active and Executive supported BAME, LGBT+ and Allies, Disability and Long-Term Health Conditions and Women’s staff networks. Staff networks are employee-led groups formed around interests, issues and a common bond or background. Staff network members create a positive and inclusive work environment at Great Ormond Street Hospital by actively contributing to the Trust’s mission, values and efforts specific to inclusion. All of our staff networks are open to any employee.
Detailed job description and main responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience and knowledge required. For both documents please view the attachment/s below.
Person specification
GOSH Culture and Values
Essential criteria
* GOSH Values
* Understanding of Diversity and Inclusion challenges in the workplace
* Demonstrable contribution to advancing Equality, Diversity and Inclusion in the Workplace
Academic/Professional qualification/Training
Essential criteria
* Educated to degree or equivalent level in in Pharmaceutical Science or relevant scientific discipline
* Training in QMS, QA or relevant experience
Experience/Knowledge
Essential criteria
* Understanding of the principles of GMP and QA in a manufacturing environment
* Proven experience of working in a relevant technical support or QA role
* Experience in QMS management
* Previous experience in supporting training programmes development and improvement in a GMP facility EI/A
* Previous experience of delivering training to GMP staff
* IT competent (Word, Excel and Power Point)
Desirable criteria
* Experience in internal and/or external audits
* Good knowledge in supporting ATMP Manufacturing
* Previous experience of using Q-Pulse
* Experience of working in a facility holding a MIA(IMP) and/or MS licences
Skills/Abilities
Essential criteria
* Demonstrated ability to communicate information effectively both orally and in writing
* Good attention to detail and accuracy
* Demonstrated good problem-solving skills
* Demonstrated ability to prioritise and meet deadlines
* Demonstrated ability to work independently and as part of a team
* Demonstrated ability to train and supervise
* Strong computer skills