Join an award-winning global Pharmaceutical company dedicated to improving patient outcomes through quality excellence and state-of-the-art technology.
We have an exciting opportunity for an experienced Quality Assurance Manager to join the established Quality team
The Role: Full Time, Monday to Friday, On-site
As a QA Manager, you will be an active member of the Quality Department and Site Management Team
People management for the QA Department as required, including managing of workloads, setting objectives and performance development
Operational oversight of Quality Assurance Officers, Document Controller, Admin and Quality Support Officer, including responsibility for absence, sickness, and overtime
Coordinate with the Head of Quality, Lead QP, QPs, Senior QA Manager and other QA Managers in maintaining and improving the Global Quality system
Lead Site Quality Management Meetings, document and track actions, and proactively drive the resolution of identified issues
Perform and/or oversee internal audits in accordance with the internal audit schedule and ensure spot checks are being performed
Participate in MHRA inspections and client audits as site host alongside the Head of Quality
Support the introduction and development of an eQMS and/or LIMS system
Serve as the Quality SME (Subject Matter Expert) for site and global projects
Drive compliance with the site maintenance schedule through close collaboration with Production and QC teams
Review and approve deviations, complaints, CAPAs, change controls and Out of Specification (OOS) / Out of Trend (OOT) investigations
Maintain control of Quality documentation through the review and approval of SOPs, forms, logbooks, and templates
Escalate serious quality matters to the Quality Leadership Team
Support the QP in the withdrawal and recall process and reporting of quality defects to the DMRC
About You:
Degree or higher in relevant scientific area or equivalent experience in a pharmaceutical setting
A strong background in Quality Assurance (4 years+)
Aseptic or Sterile manufacturing background
Good regulatory knowledge (GMP, Safety)
Previous managerial experience
Understanding of PrOFS
Self-motivated
Salary description
£52000.00 - £60000.00 per year