Address
Form of work
SalaryDo you want to be involved in supporting the development of cutting-edge and breakthrough therapies? A steadily growing CDMO have opportunity for an experienced QA officer to join them on-site on a permanent basis.
What you’ll be doing
- Writing and reviewing quality documents, SOPs and other policies
- Supporting with QMS activities including issuing validation plans and performing risk assessments
- Support all departments with writing and assessing change controls, non-conformances, root-cause analysis, risk assessments and CAPAs
- Support with internal and external audits and other regulatory inspections
- Develop and implement training materials and sessions in-house
What we need from you
- Proven experience in cellular and/or gene therapies working in a QA role, preferably within a GMP environment
- Experience in writing QA documents, particularly SOPs
- Experience performing and managing risk assessments
- Experience with internal auditing as well as managing deviations, non-conformances and CAPAs
- Understanding of cell and gene therapies
- A BSc in life sciences, or comparable experience
What’s on offer
- Competitive salary
- Additional benefits
- Excellent opportunities for growth and personal development
- Progression opportunities
