Associate Quality Specialist

  • Cork
  • Temporary
  • JO-1811-64012_1542881423

Summary

Associate Quality Specialist (2 years)
A global BioMed company in Cork are seeking a Quality Specialist to join their competitive team.

Responsibilities:

  • Provides to the IPT knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. Deviation/NOE/LIR coaching; GCM coaching, environmental monitoring program, etc.
  • Uses knowledge to improve Quality Systems and/or Operational Quality; provide continuous improvement and execute tasks.
  • Ensure supply of high-quality product through the implementation and oversight of the Quality Management System for the site.
  • Understands and applies regulatory / compliance requirements to their role.
  • Responds to standard requests from customer needs
  • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  • Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together
  • Ensure the highest Quality, Compliance and Safety standards

Requirements:

  • 1 - 3 years experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes experience in a Quality function.
  • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  • Operational experience of at least 4 QMSs
  • Degree in Science, Engineering or similar
  • Lean Six Sigma Yellow Belt or suitable alternative
  • Demonstrated use of Leadership Behaviours
  • Quality Assurance knowledge, from both operational and educational experience
  • Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site
  • Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
  • Good communication, interpersonal skills and ability to work across teams.
  • Demonstrated ability to drive the completion of tasks
  • Proven decision making capability with accountability and responsibility

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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