GMP QA Operations Specialist - Batch Release Expert

Novartis; Österreich; Vor Ort; EUR 43.000 - 52.000; Vollzeit

Benefits dieser Stelle

Pension program

Childcare facilities

Learning and development opportunities

Worldwide career possibilities

Zusammenfassung

Novartis in Kundl, Austria is seeking a QA Operations Specialist to provide quality assurance support for drug substance manufacturing, with a focus on batch record review and GMP compliance. You will help ensure timely batch release, support audits and investigations, and contribute to maintaining the Novartis Quality Management System, working with internal teams and external partners.

The role requires solid GMP experience, fluent German and good English, and a customer‑oriented,

Qualifikationen

• Solid experience in a pharmaceutical or GMP‑regulated environment.
• Experience in Quality Assurance or quality control is preferred.
• Strong knowledge of GMP requirements.
• Results‑driven mindset with continuous improvement focus
• Strong customer focus and communication skills
• Fluent in German, basic English

Aufgaben

• Review and approval of batch manufacturing records as part of the batch release process
• Review and assessment of analytical results, certificates, and specifications
• Control and verification of batch documentation and quality records
• Support audits, inspections, and regulatory interactions, investigations related to deviations, OOS/OOE, and complaints
• Support CAPA management activities and changes to processes, documentation, and quality requirements
• Preparation and review of certificates, reports, and quality-related lists
• Communication and coordination with internal departments and external partners
• Execution of tasks in a timely, efficient, and GMP‑compliant manner

Jobbeschreibung

Novartis in Kundl, Austria is seeking a QA Operations Specialist to provide quality assurance support for drug substance manufacturing, with a focus on batch record review and GMP compliance. You will help ensure timely batch release, support audits and investigations, and contribute to maintaining the Novartis Quality Management System, working with internal teams and external partners.

The role requires solid GMP experience, fluent German and good English, and a customer‑oriented,