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.
Experience and Education:
* 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
If interested in this posting please feel free to contact Rachel Kent on or for further information.