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Associate Compliance Specialist - Manufacturing

Reference:POR073781 Location: Limerick
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Compliance Specialist

An Associate Compliance Specialist – Manufacturing is required to join a rapidly expanding Global Biopharmaceutical business in Limerick. This is an opportunity to develop your career with an award-winning business that develop life-changing medicines for serious diseases. The key focus of this role is to perform all compliance related administrative tasks necessary for supporting commercial manufacturing operations.

The Role

  • Performs administrative tasks in all areas of production as needed in accordance with cGMP standards and in compliance with written procedures.
  • As part of investigations review completed batch records and logbooks to ensure compliance with written procedure.
  • Reviews, edits, and revises controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures.
  • Monitors production processes to obtain necessary data in support of investigations and track effectiveness of changes.
  • Participates in cross-functional study teams to support and/or author investigations.
  • Gathers, trends, and analyzes process related data to drive consistency and timeliness.
  • Documents all training.
  • Assists with training of new employees.
  • Ensures all tasks are performed in a manner consistent with safety standards.
The Person
  • A 3rd Level Qualification in Life Sciences or a related field
  • Strong technical writing skills
  • Understanding of cGMP systems and processes with a particular emphasis on compliance is strongly preferred.

For further details please contact; Paula O’Reilly on 087 7094141 or send CV in confidence to