This role involves managing and maintaining quality standards, processes and procedures within the organization.
The successful candidate will be responsible for executing the Quality Risk Management (QRM) & Site Quality Risk Register (SQRR) processes, ensuring effective governance, communication and management systems are in place and maintained.
They will also execute the Quality Internal & External Audit/Inspections preparation and management processes for the site, including follow up on audit action completion, associated CAPAs, and NC Quality approval.
Duties:
* Execution of the Quality Risk Management (QRM) & Site Quality Risk Register (SQRR) processes
* Execution of the Quality Internal & External Audit/Inspections preparation and management processes
* Participation in Site risk assessments
* Execution of site and quality driven improvement projects
* Management of projects to meet strict timelines and achieve established milestones with regular updates to Quality and Site Leadership Teams
* Quality Review and Approval of SOPs, Work Instructions and forms from other departments and periodic reviews
* Responsibility for Gemba Walkdowns & Inspection Readiness Walkdowns from a Quality perspective
* Quality review and approval of quality non-conformance (NC) records
* Quality point of contact for attendance at Root Cause Analysis meetings
* Initiation and ownership of Quality non-conformance records
* Quality assessor, reviewer and approval of quality non-conformance (NC) records
Required Skills and Qualifications:
* Third level Degree in a science or pharmaceutical discipline
* 3 to 5 years experience in a quality or compliance role within the biological and/or pharmaceutical industry
* Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities
* Experience with risk management projects, data integrity and driving improvements