Description
The Advanced Therapy Good Manufacturing Practice (GMP) Unit at Guy's Hospital is seeking a highly motivated and experienced Quality Assurance professional to join their team. The successful candidate will be responsible for supporting all QA activities, ensuring compliance with UK and EU legislation, and maintaining GMP compliance.
Main Duties:
- Operate within the Pharmaceutical Quality System (PQS), reviewing planned deviations, undertaking preventive actions, and implementing audit and inspection findings.
- Assist in the management and monitoring of QA and QC activities, ensuring quality standards are maintained.
- Undertake strategic judgements based on specialist knowledge of the manufacturing process.
- Contribute to quality meetings, track progress of open deviations, and report on KPIs.
- Understand and assist in the design and qualification of a new electronic PQS system.
Requirements:
- BSc in Immunology, Haematology, or equivalent experience.
- 2 years of experience working in Quality Assurance.
- Expert knowledge and hands-on experience of Good Manufacturing Practice (GMP) or equivalent.
- Experience with process qualification and equipment validation for GMP.
- Ability to work independently and as part of a team.
- Ability to communicate complex ideas verbally and in writing.
Desirable:
- PhD and/or MSc in Immunology, Haematology, or equivalent.
- Specialist knowledge relating to the manufacture of somatic cell and gene therapy products within GMP.
- Experience in cellular immunology techniques and analyses.
- Specialist knowledge of deviation management within a pharmaceutical quality system.
- Experience in training staff and students.
Salary: £47,951 to £56,863 per annum, inclusive of HCA.
Contract: Permanent, full-time.