Job title: Permanent QMS Specialist (cGMP)
Location: Cambridgeshire, 2-3 days working from home
Salary: Up to £45,000 (Flexibility dependent on experience) and competitive benefits package
Do you want the opportunity to develop and improve a robust Quality Management System, for an organisation who is setting their QA infrastructure in place? If so, this may just be the opportunity for you..
An innovative Bio-pharmaceutical company specialising in biologics are seeking to appoint an ambitious, adaptable and energetic QMS Specialist to join a rapidly growing cell therapy company. This is a newly created role and will report into the Head of Quality.
If you're looking for an opportunity to join a pioneering company at the forefront of cell therapy and one that will provide a platform for you to further develop your career and where culture is important then this may be the right opportunity for you.
What will you be doing?
The QMS Specialist you will develop quality systems and establish procedures which involved the documentation and monitoring of processes such as CAPAs, deviations, root cause analysis and non-conformities, whilst preparing for internal and external audits.
What skills/experience should you have?
Background in Biologics - preferably Stem Cells/Cell or Gene Therapy
Experience in QMS processes - CAPA, deviations and change control
Supporting continuous improvement activities
Writing and reviewing QA related documentation
Regulated to GMP or HTA
Good understanding of data integrity will be highly advantageous
If you're interested in this opportunity please use a cover letter to highlight how you meet the requirements for the role. Your cover letter along with your CV will be used to assess your application
Corrective And Preventive Action (Capa)
Quality Management Systems
Good Manufacturing Practices