Regulatory Compliance Expert

4 days ago


Dublin, Dublin City, Ireland Cpl Healthcare Full time
About the Position

Cpl Healthcare is seeking an experienced Regulatory Compliance Expert to join their team in Dublin as part of an 11-month fixed-term contract. In this role, you will be responsible for ensuring that all analytical methods and procedures are compliant with regulatory requirements.

The successful candidate will be responsible for coordinating and reviewing responses to agency questions on analytical methods, supporting importation testing queries, and implementing analytical methods in Official Medicines Control Laboratories (OMCL) and National Control Laboratories (NCL).

Key Responsibilities:

  • Coordinating and reviewing responses to agency questions on analytical methods
  • SUPPORTING IMPORTATION TESTING QUERIES
  • Implementing analytical methods in OMCL and NCL
  • Representative on cross-functional analytical and product teams

Requirements:

  • B.Sc. degree in biological/chemical sciences or related technical degree
  • Minimum 4-6 years working experience within QA/QC GMP environment
  • Working knowledge of six sigma, Lean Tools/management systems
  • Ability to work independently and as part of a team


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