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Contact Info
Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Quality Systems Project Manager


Reference:RK9095 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: BD Manager, Quality Systems Specialist

Quality Systems Project Manager
RK9095
Contract - 12 months
Remote



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. 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:

  • Develop & manage project plans , timelines and budgets .
  • Co-ordinate with internal and external steakholders to ensure all milestones are met
  • Identify , manage and mitigate project risks and issues.
  • Ensure the organisations data submissions to EUDAMED comply with EUMDR requirements.
  • Stay updated on regulatory changes and provide guidance on EUDAMED – related compliance matters.
  • Collaborate with quality assurance, IT and other relevant departments to ensure seamless integration and operation of EUDAMED processes.
  • Develop and deliver change management processes to maintain data integrity


Experience and Education:
  • A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field.
  • 10 years related experience.
  • Experience working in both an FDA and European regulatory environment is preferred.
  • This position will require relevant experience working in manufacturing/operations.
  • In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.


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