Do 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