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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Quality Management System Specialist


Reference:RK21220 Location: Cork
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Quality Systems Specialist

Quality Management System Specialist
RK21220
Contract – 11 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:

  • Provides to the site knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications/ Investigations/ Change Management
  • Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.
  • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
  • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  • Supports Corporate Quality to ensure actions related to Quality Systems and/or Operational Quality at the site are executed.
  • Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
  • Ensure supply of high-quality product through the implementation and oversight of the Quality Management System for the site.
  • Ensure the highest Quality, Compliance and Safety standards.
  • The Associate Specialist/ Specialist will participate and comply with the Quality Management System (QMS) requirements, including ownership.
  • The Associate Specialist/ Specialist is accountable for the smooth execution of all appropriate documentation associated within the IPT/QA. He/ She will contribute to the High-Performance culture within the IPT/QA by providing a flexible, accurate service to enable the IPT/QA to achieve four key priorities.
  • Is an active member of the cross functional IPT/QA Team, providing support, guidance and expertise to ensure the success of the IPT/QA.
  • Will participate and comply with the Quality Management System (QMS) requirements, including ownership.



Experience and Education:
  • MSc/BSc. qualification (Science)
  • 4 years’ experience in a pharmaceutical or a highly regulated environment preferably with cGMP experience
  • Experience with Site Documentation Systems including Issuance, reconciliation, storage, archiving and retrieval of cGMP documentation to support the manufacture & testing of our products.



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