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Regulatory Compliance Officer

1 week ago

Nenagh, County Tipperary, Ireland Recruitment By Aphex Group Full time
About the Role

The Regulatory Compliance Officer will be responsible for ensuring compliance with regulatory requirements and maintaining a strong quality system within the organization. The officer will participate as a member of the quality systems team and provide leadership through knowledge and skill regarding validation standards required for a pharmaceutical facility.

The key responsibilities include:
  • Compliance: ensure compliance with regulatory requirements and maintain a strong quality system.
  • Validation: approve all validation documentation and ensure compliance to MMD policies, procedures, and guidelines.
  • Change control: support the implementation of site or capital projects by defining validation requirements and providing technical assistance and support.
  • Quality planning: develop validation summary reports and assist in developing overall quality plans for major projects.
  • Laboratory QA oversight: support and approve systems supporting laboratory functions, instrumentation, and GLIMS.

Key Skills and Qualifications:
  • Minimum of degree or post-graduate qualification in science, pharmacy, or engineering field.
  • Understanding of validation principles and guidelines.
  • Ability to make decisions and prioritize based on business drivers.
  • Proficiency in computer applications including Word, Excel, Access, e Logs, File and Email Management.
  • Meetings management, technical report writing, time management, analytical problem-solving skills, and continuous improvement skills.