QA Manager - GxP

CW Recruitment Specialist
£Exc + bens
28 Sep 2016
20 Oct 2016
Contract Type
CWRS invites applications on behalf of their biopharmaceutical client where an excellent opportunity has now arisen for a permanent QA Manager based in Livingston . Job Purpose: This role will support the maintenance and improvement of Quality systems and processes, ensuring Group products, services and systems meet the appropriate regulatory and Group standards. Key duties include: · Ensuring continual improvement across the company via the review of feedback and inspection from internal and external sources. · Maintenance and review of Controlled Documentation within the Quality Management System. · Maintenance of key quality management system processes, for example: · Incident Management · Complaints · CAPA · Supplier Approval · Validation protocol and report review and approval · Performing internal audits and study-specific audits for GCP compliance. Reporting findings to appropriate personnel and monitoring progression of actions to ensure prompt completion through the CAPA system · Hosting Client audits or Regulatory inspections and the development of responses to subsequent reports. · Maintain up to date knowledge of relevant regulatory requirements. · Being a point of contact for QA Officers and providing guidance and support, where applicable. · Providing training in applicable QA concepts and providing the appropriate quality inductions to new recruits. · Provide staff training in the Quality Management System and the Principles of GCP or GMP as appropriate and identifying relevant quality-related training needs. · Liaise with client’s/sponsor’s auditors and ensure execution of corrective action and compliance with customers’ specifications comply with safe working practices in accordance with Company safety policies. · Ability to travel to all facilities within the group as required. The ideal candidate will be/have: · Previous QA experience in a GxP environment · Suitably qualified in a relevant discipline · Ability to travel between sites, as required · Evidence of leadership and readiness to step into a management role. This job was originally posted as