Qualified Person – Pharmaceutical Quality Release

Novartis; Tirol; Vor Ort; EUR 78.000 - 158.000; Vollzeit

Benefits dieser Stelle

Relocation support

Hybrid working options

Parental leave

Insurance plans

Retirement plans

Zusammenfassung

Novartis in Schaftenau, Austria, seeks a Qualified Person (QP) to certify and release medicinal products in line with AMG, AMBO 2009 and EU GMP Annex 16. Based in Austria, you will ensure that every batch is manufactured and tested in full compliance with the Austrian Medicines Act and current GMP requirements.

The role includes reviewing GMP documentation, approving deviations, supporting validation and technology transfer, and leading quality projects. Relocation assistance is available.

Qualifikationen

• Qualified Person qualification in accordance with AMBO 2009.
• University degree in Pharmacy, Biochemistry, Biotechnology, Chemistry or Microbiology.
• At least 2 years of experience as Qualified Person in QA/QC.
• Thorough knowledge of cGMP and quality standards.
• Fluent German and English, written and spoken.

Aufgaben

• Certify and release batches of finished dosage forms for commercial supply.
• Act as Qualified Person under AMBO 2009 and EU GMP Annex 16.
• Review and approve GMP documentation including BOMs, master batch records, stability protocols, APQRs, CAPAs and re-packaging requests.
• Review and approve quality control documentation and QC procedures.
• Assess deviations and quality events with robust root-cause analysis and timely actions.
• Contribute to validation, technology transfer, risk management, SOPs, recalls, investigations.
• Lead or participate in quality and product projects, audits and inspections to ensure inspection readiness and quality culture.

Kenntnisse

Qualified Person

German/English fluency

GMP quality assurance

Quality mindset

Ausbildung

Pharmacy/Biochemistry/Biotechnology/Chemistry/Microbiology degree

Jobbeschreibung

Novartis in Schaftenau, Austria, seeks a Qualified Person (QP) to certify and release medicinal products in line with AMG, AMBO 2009 and EU GMP Annex 16. Based in Austria, you will ensure that every batch is manufactured and tested in full compliance with the Austrian Medicines Act and current GMP requirements.

The role includes reviewing GMP documentation, approving deviations, supporting validation and technology transfer, and leading quality projects. Relocation assistance is available.