QA Manager

Job description

Looking for a QA role that challenges your thinking as much as it values your expertise?

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

Reference 225693872