Senior Quality Assurance Specialist

🧬 Senior Quality Specialist GMDP

📍 Vienna, Austria

🕒 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

🏢 Role Context

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.