QA Assistant

1 month ago


Cambridge, United Kingdom Next Phase Recruitment Limited Full time

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


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