QA Batch Release & QMS Support Specialist

Biocon Biologics; Dublin; On-site; EUR 70,000 - 100,000; Full time

Job summary

Biocon Biologics in Ireland is hiring a QA Operations Support Specialist to provide practical support to the QP function, focusing on batch release preparation, document review, packing release activities, and EU laboratory QMS support.

You will coordinate change controls, deviations, and QMS inputs, maintain release trackers, and contribute to continuous improvement while progressing toward QP education.

Qualifications

• Degree in a relevant science discipline and GMP/GDP awareness.
• Typically 10+ years' experience in QA, batch review, QA operations, or QMS support.
• Experience with biosimilar batch file review and GMP/GDP documentation.
• Progressing towards, or interested in, education aligned with the QP pathway.

Responsibilities

• Prepare batch release documentation packs for QP review and certification.
• Perform initial review of biosimilar batch files, packing release records, CoAs/CoCs.
• Identify documentation gaps and elevate release concerns to QA/QP.
• Maintain release trackers and follow-up actions to support timely batch progression.
• Raise and coordinate change controls and deviations under QA guidance.
• Support QP-related QMS inputs, including PQRs, complaint trends, metrics, and routine review materials.
• Assist with EU laboratory QMS documentation and temperature evaluation summaries.
• Review and streamline QMS functions as part of continuous improvement.

Skills

Attention to detail

Coordination skills

Written and verbal communication

Self-motivated

Organizational skills

Education

Degree in pharmacy, chemistry, biology, biotechnology, pharmaceutical sciences, life sciences, or related discipline

Job description

Biocon Biologics in Ireland is hiring a QA Operations Support Specialist to provide practical support to the QP function, focusing on batch release preparation, document review, packing release activities, and EU laboratory QMS support.

You will coordinate change controls, deviations, and QMS inputs, maintain release trackers, and contribute to continuous improvement while progressing toward QP education.