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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Senior Quality Assurance Specialist


Reference:RK3368 Location: Cork
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Manager

Senior Quality Assurance Specialist(hybrid)
RK3368
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:

  • Batch Record Review and material release (including CoA) to ensure compliance with GMP requirements.
  • Quality review and approval of Master Batch Record
  • (MBR) record for routine cleaning and process activities, including Automation recipe updates.
  • QA Review and Approval of SOPs, Work Instructions and forms from other departments.
  • Attendance at Daily/Weekly Operations led Team Meetings.
  • Responsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a QA perspective.
  • QA review and approval of Warehouse Shipping Picklist.
  • Primary QA point of contact for Quarantine Shipments.
  • Responsible for Batch Book Filing & Archival.
  • QA review and approval of quality non-conformance (NC) records and customer complaint non-conformance records.
  • Initiation and ownership of QA non-conformance records.
  • Responsible for periodic review of Quality Assurance and Quality Systems SOPs.
  • Primary Quality point of contact for attendance at Root Cause Analysis meetings.
  • Primary QA point of contact for the Returns process.

Experience and Education:
  • Third level Degree in a science or pharmaceutical discipline.
  • A minimum of 3 years of experience within the Pharmaceutical Industry.
  • A working knowledge of quality processes and systems is desirable.
  • Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.

If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.