Quality Systems Associate

Location: Central London  |  Greater London  |  England
Sector: Life Sciences
Consultant: Life Sciences Team
Job Reference: CC - HQ0977
Salary: £30000 - £35000
Job Status: Permanent / Full Time

Job description – Quality Systems Associate

Salary: £35,000

Location: Central London

Hours: 37.5hrs per week

Duties of work shall include:

  • Managing the SOP log
  • Managing the CAPA, Audit, Change control, SCARS, Deviations, Complaints logs etc.
  • Logging of CAPAs, Audits, Change Controls, SCARs, Deviations, Complaints etc. – and chase up of actions for closure
  • Track and trending of CAPAs, Change Controls, SCARs, Deviations, Complaints etc.
  • Review and Issuing of SOPs
  • SOP training
  • Managing the training matrix
  • Issuing of Specifications, drawings and artwork to suppliers as necessary
  • Training of employees in quality related activities
  • Maintenance of training records for employees
  • Scheduling internal and external audits and maintaining the schedules
  • Maintaining the ASL
  • Scheduling regular quality meetings – internally and with suppliers
  • Writing up of meeting agendas and meeting minutes 
  • Providing data in relation to Quality matrix, Objectives and KPI
  • Providing data in relation to Management Review
  • Support regarding documentations related to the maintenance of CE technical file
  • Maintaining original QA documentation that has been generated internally and externally
  • Maintaining a compliant digital system of QA documentation
  • To support in the management of the QMS

Experience, Personal and Professional Qualifications
We are seeking an individual who has previous experience of ISO13485:2016, GMP or GDP.

–       You will need at least 3 years relevant QA experience

–       Your expertise will ideally cover ISO13485:2016/GMP/GDP compliance

–       A degree in Life Science or Applied Sciences with relevant experience within both Medical Devices and Pharmaceutical industry