THE ROLE

To provide full administrative support for the Quality Control and Assurance activities of the company in relation to QMS Compliance and the management of APL’s eQMS, supporting other departments with its usage, in order to ensure continued EU/UK GXP/ISO Compliance.

WHAT WILL YOU BE DOING?

• QMS Compliance activities to maintain compliance with Aspire Pharma Limited’s EU and UK GXP/ISO 9001/ISO 13485/ ISO14971 Quality Management System.
• Day to day activities include; staff training; documentation control; change control; non-conformance/deviations; validation; corrective and/or preventive actions; regulatory intelligence; internal audits; self-inspections; management review; monthly checks; licence variations; and launch activities for area.
• Maintaining awareness of existing and new legislation/guidance relating to EU and UK GXP (including GMP, GDP, GVP and GCP).