Onsite QC Specialist II: GxP, Audits & CI

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH; Schaftenau; Vor Ort; EUR 61.000 - 96.000; Vollzeit

Benefits dieser Stelle

Modern company pension scheme

Flexible hybrid working options

Parental leave (14 weeks)

Zusammenfassung

Novartis Pharmaceutical Manufacturing GmbH in Schaftenau, Austria is seeking a QC Specialist to support reliable laboratory operations and ensure high quality standards in a cGxP environment.

You will oversee production/testing, review QC data, manage deviations and CAPAs, aid batch release, and contribute to audits and continuous improvement, with fluency in German and English and a collaborative, solution‑oriented approach.

Qualifikationen

• Education as a Lab Technician or university degree in a scientific or technical field.
• Professional experience in a pharmaceutical laboratory, QC, QA, analytics, or GMP-regulated environment.
• Strong knowledge of GMP, GxP, quality control testing, quality assurance, and quality documentation.

Aufgaben

• Oversee production and testing activities to ensure cGxP compliance.
• Review and approve QC testing results, production documentation, QC records, and AS&T records.
• Support exception, deviation, and investigation processes with documentation.
• Ensure QC activities follow GMP, GxP, regulatory and internal quality standards.
• Support batch release activities in compliance with GMP and license requirements.
• Contribute to audit readiness and support during GxP audits and inspections.
• Maintain analytical equipment qualification, calibration status, and lab documentation.

Kenntnisse

GxP knowledge

GMP compliance

Quality control

Analytical testing

German language

English language

Ausbildung

Lab Technician or science/technical degree

Jobbeschreibung

Novartis Pharmaceutical Manufacturing GmbH in Schaftenau, Austria is seeking a QC Specialist to support reliable laboratory operations and ensure high quality standards in a cGxP environment.

You will oversee production/testing, review QC data, manage deviations and CAPAs, aid batch release, and contribute to audits and continuous improvement, with fluency in German and English and a collaborative, solution‑oriented approach.