Regulatory Writer

4 days ago


Limerick, Limerick, Ireland TN Ireland Full time

Job Summary

TN Ireland is seeking a highly skilled Regulatory Writer to join our team.

This role involves creating high-quality regulatory documents, including GMP documents, labeling, and packaging information.

  • You will work closely with regulatory affairs specialists to develop and maintain accurate and up-to-date content.
  • Strong knowledge of regulatory requirements, such as Good Documentation Practices (ALCOA), ISPE Standards, and GAMP5, is essential for this role.

Responsibilities

  • Develop and maintain GMP documents, including standard operating procedures, system design documents, and work instructions.
  • Conduct compliance reviews of electronic work tickets to ensure adherence to Good Documentation Practices/Requirements.

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