Summary: The QA Operations Specialist role involves overseeing the review and approval of Master Batch Records and production documentation within a leading pharmaceutical company specializing in veterinary vaccines. The position requires a seasoned professional with extensive experience in GMP manufacturing and quality assurance, particularly in the biotech industry. The role is crucial for ensuring compliance with regulatory standards and supporting various quality assurance activities. This is an 11-month contract based in Dublin, Ireland.

Key Responsibilities:

• Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
• Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMP and company procedures
• Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Re-qualification and Periodic review, Site Maintenance & Calibration Program

Key Skills:

• Extensive relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations
• At least 5 years working knowledge in the biotech industry with specific understanding of QA operations
• Experience working on manufacturing shop floor
• Familiarity with GMP documentation review and/or shop floor auditing

Salary (Rate): undetermined

City: Dublin

Country: Ireland

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other