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Salary: EUR 85,300 - 158,300 / annual
DTX Pharma (a Novartis Company) seeks an experienced Qualified Person (QP) to join its manufacturing site in Schaftenau, Austria. This role is responsible for the final certification and release of medicinal products in full compliance with Austrian pharmaceutical regulations (AMBO 2009), EU GMP Annex 16, and the Austrian Medicines Act (AMG).
Key responsibilities include: certifying and releasing secondary-packed finished dosage form batches for commercial supply; reviewing and approving critical GMP documentation (bills of materials, master batch records, stability protocols, APQRs, CAPAs, quarantine requests); reviewing and approving quality control documentation (specifications, sampling instructions, test methods); assessing and approving deviations, out-of-specification investigations, and quality events with robust root-cause analysis; and contributing to validation, technology transfer, risk management, SOP development, process changes, recalls, and complaint investigations.
The QP will lead or actively participate in quality and product-related projects, trainings, audits, and inspections to strengthen compliance and quality culture. This is a hybrid role based in Schaftenau, a modern manufacturing site in the Austrian Alps with approximately 3,500 employees across the Tyrol region.
Required qualifications: formal QP qualification per AMBO 2009; university degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology, or equivalent scientific discipline; minimum 2 years of experience as a QP in pharmaceutical or biopharmaceutical quality assurance or quality control; thorough knowledge of cGMP and applicable quality standards; fluent German and English (written and spoken); demonstrated accountability, sound decision-making, teamwork, results orientation, and commitment to quality and continuous improvement.
Novartis offers relocation support, competitive benefits including insurance, retirement plans, wellbeing resources, flexible/hybrid working options, and a minimum of 14 weeks paid parental leave. Salary is determined based on skills, competencies, and experience, with performance-based bonus eligibility.
