Job summary
Quality Assurance Associate - Cell & Gene Therapy Service
An excellent opportunity has presented itself at Cell and Gene Therapy Service, Great Ormond Street Hospital for a Quality Assurance Associate position. 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 Cell and Gene Therapy Service manufactures life-saving therapies for paediatric patients under MHRA licence. Our new state of the art, purpose-built facility (ZCR) are licensed by the MHRA to allow us to function within the terms of our MIA(IMP) and MS licences.
The Quality Assurance Associate will support and advise the manufacturing team in the development, review and approval of key documentation for use in the ATMPs manufacture. The postholder will lead a team of Senior QA technicians to ensure the review of batch manufacturing records post-manufacture and prior to QP certification. The postholder will also ensure all manufacturing quality records and all relevant QA activities were managed in line with internal process and in compliance with regulatory requirements.
Main duties of the job
The postholder as a member of the Quality Assurance 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.
We are therefore seeking a candidate with a strong background in Quality Assurance, a comprehensive understanding of GMP principles and previous experience in the field of ATMPs. The ideal candidate should demonstrate excellent leadership and line management experience, organisational skills, attention to detail, and problem-solving abilities. Effective communication, both written and verbal, is crucial for collaborating with internal teams and external partners.
This is a fantastic opportunity to join our friendly and welcoming Quality team with its great diversity of skills and experience, we look forward to receiving your application.
For further information, please contact:
Shok Ping Lim (shokping.lim@gosh.nhs.uk)
About us
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.
Job description
Job 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.
Job description
Job 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
Academic/Professional qualification/Training
Essential
- Educated to BSc level in relevant scientific discipline
- Training in QMS, QA or relevant experience
- Postgraduate in appropriate speciality or similar level of experience
Experience/Knowledge
Essential
- Demonstrated practical knowledge of QA, GMP, GCP and all current relevant regulations
- Good understanding and knowledge of cell and gene therapies
- Experience of working in a QA environment
- Experience in QMS (deviations, change controls, CAPAs, QRAs) management
- Experience of managing a team
- Proven experience in QA review of manufacturing batchrelated documentation and batch manufact
- Demonstrated knowledge of the qualification and validation requirements for ATMP products
- Proven experience of delivering training
- Experience in starting and raw materials management for ATMP manufacture
- IT competent (Word, Excel and Power Point)
Desirable
- Experience in supplier assessment and approval
- Experience in internal and/or external audits
- Proven experience working in a relevant GMP, QA or production role
- Experience of using Q-Pulse
- Experience of working in a facility holding a MIA(IMP) and/or MS licences
Skills/Abilities
Essential
- Strong organisational skills and demonstrated ability to prioritise and meet deadlines
- Good problem-solving skills
- Good attention to detail and accuracy
- Strong communication skills, both verbal and written
- Ability to accurately follow written and oral instructions
- Ability to work independently and as part of a team
- Training of staff
- Personnel management
- Show initiative and provide support to other staff members
- Ability to self-motivate and show a positive attitude
Person Specification
GOSH Culture and Values
Essential
Academic/Professional qualification/Training
Essential
- Educated to BSc level in relevant scientific discipline
- Training in QMS, QA or relevant experience
- Postgraduate in appropriate speciality or similar level of experience
Experience/Knowledge
Essential
- Demonstrated practical knowledge of QA, GMP, GCP and all current relevant regulations
- Good understanding and knowledge of cell and gene therapies
- Experience of working in a QA environment
- Experience in QMS (deviations, change controls, CAPAs, QRAs) management
- Experience of managing a team
- Proven experience in QA review of manufacturing batchrelated documentation and batch manufact
- Demonstrated knowledge of the qualification and validation requirements for ATMP products
- Proven experience of delivering training
- Experience in starting and raw materials management for ATMP manufacture
- IT competent (Word, Excel and Power Point)
Desirable
- Experience in supplier assessment and approval
- Experience in internal and/or external audits
- Proven experience working in a relevant GMP, QA or production role
- Experience of using Q-Pulse
- Experience of working in a facility holding a MIA(IMP) and/or MS licences
Skills/Abilities
Essential
- Strong organisational skills and demonstrated ability to prioritise and meet deadlines
- Good problem-solving skills
- Good attention to detail and accuracy
- Strong communication skills, both verbal and written
- Ability to accurately follow written and oral instructions
- Ability to work independently and as part of a team
- Training of staff
- Personnel management
- Show initiative and provide support to other staff members
- Ability to self-motivate and show a positive attitude
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.
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).
Additional information
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.
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
Great Ormond Street Hospital for Children NHS Foundation Trust
Address
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
Employer's website
https://www.gosh.nhs.uk/ (Opens in a new tab)
