Aseptic QA Specialist - 12h Shift, Onsite, GMP

The Innopharma Group; Ireland; On-site; EUR 42,000 - 68,000; Full time

Job summary

Innopharma Group's Innopharma Technical Services is seeking a Quality Assurance Specialist to support QA activities within our bio/pharma manufacturing environment in Leinster. The role reports to the Quality Manager and is shift-based and onsite.

The successful candidate will review batch documentation, investigations, and reports; ensure cGMP compliance; work with SAP, Trackwise and MES; and collaborate across functions to maintain high quality standards.

Qualifications

• Bachelor's degree in Science (or equivalent)
• 1-2 years’ experience in a quality role in a pharmaceutical manufacturing facility (aseptic preferred)
• Working knowledge of Irish/EU/International regulatory requirements
• Knowledge of cGMP and GDP
• Experience with quality systems and document control

Responsibilities

• Review batch documentation, investigations and reports and assist in issue resolution
• Respond to unplanned events and technical issues promptly
• Maintain audit readiness and cGMP compliance through active quality control activities
• Support production lines and spot-check/walk-through processes
• Collaborate cross-functionally to promote GMP improvements and regulatory compliance

Skills

Quality systems

Documentation

Regulatory knowledge

Team collaboration

Education

Bachelor's Degree in Science

Tools

SAP

Trackwise

MES

Job description

Innopharma Group's Innopharma Technical Services is seeking a Quality Assurance Specialist to support QA activities within our bio/pharma manufacturing environment in Leinster. The role reports to the Quality Manager and is shift-based and onsite.

The successful candidate will review batch documentation, investigations, and reports; ensure cGMP compliance; work with SAP, Trackwise and MES; and collaborate across functions to maintain high quality standards.