Senior QA Specialist: Lean Batch Release & PQR (Hybrid)

Valtera Group Ltd; Wien; Hybrid; EUR 70,000 - 95,000; Full time

Job summary

Valtera Group Ltd in Vienna is seeking an experienced Quality Assurance expert for batch review, release, and lean PQR development. The role combines on-site work with cross-site collaboration to ensure reliable supply as new product transfers occur.

The specialist will lead deviation investigations, CAPA and change controls, supporting eQMS implementation and quality inspections throughout the portfolio.

Qualifications

• Degree in Pharmacy, Life Sciences, Chemistry, Biotechnology or related.
• Several years of hands-on QA experience in pharma.
• Strong knowledge of EU GMP and GDP requirements.
• Experience reviewing batch documentation, deviations, investigations and CAPAs.
• Familiarity with Product Quality Reviews (PQR) and batch release processes.

Responsibilities

• Review batch documentation and prepare GMP batch certification and GDP release across the full product portfolio.
• Design and implement a lean Product Quality Review process and assess PQRs.
• Streamline batch release processes for efficiency across sites.
• Lead deviation investigations including root cause analysis and CAPA implementation.
• Coordinate change controls and support complaints, investigations and recalls.
• Review artworks and packaging against specifications and regulatory requirements.
• Act as Quality partner to the secondary packaging site with on-site visits.
• Support eQMS implementation and GMP/GDP inspections.

Skills

EU GMP & GDP knowledge

Batch review & release

CAPA root cause analysis

Deviations investigations

Quality Assurance experience

English language

German language

Analytical skills

Cross-site collaboration

Education

Pharmacy / Life Sciences degree

Tools

eQMS software

GMP documentation tools

Job description

Valtera Group Ltd in Vienna is seeking an experienced Quality Assurance expert for batch review, release, and lean PQR development. The role combines on-site work with cross-site collaboration to ensure reliable supply as new product transfers occur.

The specialist will lead deviation investigations, CAPA and change controls, supporting eQMS implementation and quality inspections throughout the portfolio.