Senior Quality Assurance Specialist

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

Permanent, hybrid with at least 3 days per week on site

Batch review, release and lean PQR processes across the full portfolio

Pharmaceutical Quality Assurance, EU GMP and GDP

A fast-growing European pharmaceutical company is adding an experienced specialist to its Vienna Quality Operations team. This is an expert-track role with no line management. It covers batch record review and release across the full product portfolio, with a strong focus on building a lean Product Quality Review process.

You will join a direct, hands-on team working closely with supply chain and quality colleagues at another European site. Your work will directly support reliable supply as new product transfers and quality system projects begin.

What You Will Do

• 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, then compile and critically assess PQRs.


• Streamline batch release processes so they work efficiently for all sites and stakeholders.


• Lead deviation investigations, including root cause analysis, impact assessment and effective CAPA implementation.


• Coordinate change controls and support complaints, quality investigations and product recalls.


• Review artworks and packaging materials against approved specifications and regulatory requirements.


• Act as a key Quality partner to the secondary packaging site, with regular on-site visits.


• Support eQMS implementation, transfers to new contract manufacturers, and GMP/GDP inspections and audits

What We’re Looking For

• Degree in Pharmacy, Life Sciences, Chemistry, Biotechnology or a related scientific discipline.


• Several years of hands‑on Quality Assurance experience in the pharmaceutical industry.


• Solid, practical knowledge of EU GMP and GDP requirements.


• Hands‑on experience reviewing batch documentation, deviations, investigations, CAPAs, complaints, and supplier qualification.


• Familiarity with Product Quality Reviews (PQR's) and batch release processes, with the ability to contribute from day one.


• Sound judgement on critical versus non‑critical issues, with strong analytical and prioritisation skills.


• Proactive, organised and reliable, able to work independently and collaborate across sites and functions.


• Fluent German and English, written and spoken.


• A valid driving licence is an advantage.