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.

• 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.