Salary Range: €85,300.00 - €158,300.00 Job Description Summary LI-Hybrid Location: Schaftenau, Austria The Qualified Person (QP / Sachkundige Person) is responsible for the final certification and release of medicinal products in accordance with § 7 of the Arzneimittelbetriebsordnung (AMBO 2009). Based in Austria, you will ensure that every batch is manufactured and tested in full compliance with the Austrian Medicines Act (AMG), the Marketing Authorization, and current GMP requirements. Job Description This role is based in Schaftenau, Austria. Major Accountabilities: - Certify and release secondary packed finished dosage form batches for commercial supply, ensuring compliant technical and market release decisions. - Act as Qualified Person in accordance with AMBO 2009 and EU GMP Annex 16 , covering medicinal products for human and veterinary use where applicable. - Review and approve key GMP documentation, including bills of materials, master batch records, stability protocols and reports, APQRs, CAPAs, quarantine shipment requests, and re-packaging requests.



- Review and approve quality control documentation, including specifications, sampling instructions, test methods, and other QC procedures. - Assess and approve deviations, OOX investigations, and quality events, ensuring robust root-cause analysis, appropriate corrective actions, and timely closure. - Contribute to validation, technology transfer, risk management, SOP development, process change evaluations, recalls, complaint investigations, and other quality-critical activities. - Lead or actively participate in quality and product-related projects, trainings, audits, and inspections to strengthen compliance, inspection readiness, and quality culture. Obligatory Requirements: - Qualification as a Qualified Person in accordance with AMBO 2009. - University degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology , or an equivalent scientific discipline. - At least 2 years of experien

📌 Qualified Person (Iquitos)
🏢 Novartis
📍 Iquitos