A Quality Specialist Risk Management is required by CareerWise Recruitment to join our based Cork based pharma manufacturing client - 12-month initial contract role.
This position is responsible for Quality Risk Management and Quality Systems compliance activities as required by Good Manufacturing Practice (GMP).
Role: * Execution of the Quality Risk Management (QRM) & Site Quality Risk Register (SQRR) processes ensuring effective governance, communication and management systems are in place and maintained.
* Execution of 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).
* Participate in Site risk assessments.
* Execute site and quality driven improvement projects as per the site Risk Register e.g. but not limited to, Supplier Qualifications, Reclassification of plant areas, Site Data Integrity Program * Manages projects effectively 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.
* Responsible 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.
Requirements: * Third level Degree in a science or pharmaceutical discipline.
* A minimum of 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.
Please call Diarmuid Buckley today for further information on or email: CareerWise Recruitment (In Search of Excellence) Established in ****, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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Skills: Quality Specialist GMP