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

Valtera Group Ltd; Wien; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

Valtera Group Ltd in Vienna is seeking an experienced Quality Assurance specialist for a permanent, hybrid role with at least three days on site. You will review batch documentation, lead PQR initiatives, and support lean release processes across the portfolio.

Collaboration with supply chain and cross-site QA teams is essential for compliant product transfers and inspections. The role emphasizes hands-on QA with EU GMP and GDP compliance and requires fluency in German and English.

Qualifications

• Degree in Pharmacy, Life Sciences, Chemistry, Biotechnology or related field.
• Hands-on QA experience in pharma.
• Knowledge of EU GMP and GDP requirements.
• Experience reviewing batch documentation, deviations, investigations, CAPAs, complaints, and supplier qualification.
• 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 critically assess PQRs.
• Streamline batch release processes for sites and stakeholders.
• Lead deviation investigations with root cause analysis and CAPA implementation.
• Coordinate change controls and support complaints, quality investigations and recalls.
• Review artworks and packaging against specifications and regulatory requirements.
• Act as a Quality partner to the secondary packaging site with on-site visits.
• Support eQMS implementation and GMP/GDP inspections and audits.

Skills

Quality Assurance

EU GMP

Root cause analysis

CAPA

PQR reviews

Batch release

Education

Pharmacy or Life Sciences degree

Regulatory knowledge

Job description

Valtera Group Ltd in Vienna is seeking an experienced Quality Assurance specialist for a permanent, hybrid role with at least three days on site. You will review batch documentation, lead PQR initiatives, and support lean release processes across the portfolio.

Collaboration with supply chain and cross-site QA teams is essential for compliant product transfers and inspections. The role emphasizes hands-on QA with EU GMP and GDP compliance and requires fluency in German and English.