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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Senior Quality Specialist - Risk Management


Reference:RK3939 Location: Cork
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Quality Specialist

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 +353 (0)87 427 8808 or [email protected] for further information.