Qualified Person (QP/Sachkundige Person) (m/w/d)

Qualified Person (QP/Sachkundige Person) (m/w/d)

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.

About the Role

This role is based in Schaftenau, Austria. Novartis can offer relocation support for this role.

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 experience as Qualified Person in the pharmaceutical or biopharmaceutical industry in Quality Assurance and/or Quality Control department.
• Thorough knowledge of cGMP requirements and applicable quality standards.
• Accountability, sound decision-making, teamwork, results orientation, customer focus, and a strong commitment to quality and continuous improvement.
• Fluent German and English language skills, both written and spoken.

Benefits & Rewards

For this position the minimum salary according to collective bargaining agreement is € 78.383,90 per year on a full-time basis. The expected annual base salary range for the role is EUR 85,300 - 158,300. The actual salary is determined based on relevant skills, competencies and experience.

Additional rewards may include performance-based bonus eligibility, insurance plans, retirement plans, wellbeing resources, global recognition programs, flexible and hybrid working options where possible, and a minimum of 14 weeks paid parental leave.