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Quality Assurance Professional

2 weeks ago

Cluain Meala, County Tipperary, Ireland beBeeRegulatory Full time €60,000 - €75,000
Quality Assurance Professional

Our organization is a leading provider of active ingredients and final formulated products for innovative medicines. We have manufacturing and R&D facilities operating for over 40 years, exporting to more than 25 countries worldwide with primary markets in Europe, USA, and Japan.

Key Responsibilities:
  • Utilize knowledge and experience in Quality Systems and Operational Quality to provide expertise in Quality Notifications/Investigations/LIR coaching, GCM coaching, environmental monitoring program, sterility assurance/low bio-burden manufacturing, customer complaint investigations, etc.
  • Apply knowledge to improve Quality Systems, solve problems, provide continuous improvement, and execute tasks.
  • Contribute to compliance within project teams and lead small projects.
  • Coach and guide colleagues within the organization.
  • Understand and apply regulatory/compliance requirements to their role, remaining current on upcoming regulatory and compliance changes.
  • Make decisions within guidelines and policies impacting own priorities and allocation of time to meet deadlines.
About You:
  • 1-5 years' experience in the Pharmaceutical industry or a similar operating environment with experience in a Quality function.
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (i.e., Quality, science, etc.).
  • Operational experience of at least 4 QMSs.