Senior Quality Specialist - Risk Management
RK3939
Contract - 12 months
Cork



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Duties:

• 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 CAPA’s, 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.

• 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 is a must