Dodane na: Inne w Cambridge | Ostatnio zaktualizowany: |
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