Summary: The Quality Assurance Specialist role at a leading pharmaceutical company in Tipperary involves supporting GMP Quality activities and ensuring compliance with regulatory requirements. This hybrid position requires a minimum of one day per week on-site work. The specialist will be responsible for reviewing documentation, conducting investigations, and maintaining SOPs. Candidates should have a degree in Science or Engineering, or substantial industrial experience in Quality Assurance.

Key Responsibilities:

• Review and approve production and analytical documentation for drug substances and finished goods.
• Perform and review complaints and deviation investigations, change controls, and CAPAs.
• Create and maintain assigned SOPs.
• Compile data for reports and presentations, providing data interpretation and conclusions.
• Complete audits.
• Support product recalls and stock recoveries as appropriate.

Key Skills:

• A degree in a Science or Engineering discipline plus some industrial experience.
• Considerable industrial experience within Quality Assurance.
• Batch record review experience.
• QMS experience is advantageous.

Salary (Rate): undetermined

City: Cork

Country: Ireland

Working Arrangements: hybrid

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other