Job Title: Senior Quality Specialist
We are seeking a seasoned Quality Specialist to join our team in Cork.
This is an excellent opportunity for anyone who is looking to work with a leading multinational organization in the pharmaceutical industry.
The successful candidate will have strong experience in quality management and risk assessment, as well as excellent communication and project management skills.
Key Responsibilities:
* 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).
* Participation in site risk assessments.
* Management of site and quality driven improvement projects as per the site Risk Register e.g. Supplier Qualifications, Reclassification of plant areas, Site Data Integrity Program.
* 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.
Requirements:
* Third level Degree in a science or pharmaceutical discipline.
* 3-5 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.