Quality Control Specialist II – GMP/GxP Lab Operations

Novartis; Österreich; Vor Ort; EUR 61.000 - 96.000; Vollzeit

Benefits dieser Stelle

Market-competitive base salary

Pension scheme

Childcare facilities

Global career possibilities

Hybrid working options

14 weeks parental leave

Zusammenfassung

Novartis is seeking a QC Specialist in Schaftenau, Austria, to support reliable laboratory operations, ensure GxP compliance, and review QC analyses. You will monitor testing activities, assist analysts, and contribute to audits and continuous improvement in a collaborative team.

The role requires strong GMP/GxP knowledge, lab experience, and fluency in German and English, with a focus on data integrity and regulatory documentation in a high-quality pharmaceutical environment.

Qualifikationen

• Education or degree in a scientific/technical field.
• Experience in a pharmaceutical laboratory under GMP/GxP.
• Knowledge of GMP, GxP, QC testing, QA, and documentation.
• Ability to manage deviations, CAPAs, and investigations.
• Good communication in German and English across QC/QA/production teams.

Aufgaben

• Oversee production and testing activities to ensure cGxP compliance, data integrity and eCompliance.
• Review and approve QC testing results, production documentation, QC records, and AS&T records.
• Support deviation, investigation, and CAPA processes with timely follow-up and proper documentation.
• Ensure QC activities align with GMP, GxP, regulatory and internal quality standards.
• Support batch release activities in line with GMP, registration, and license requirements.
• Assist audit readiness and support during GxP audits and regulatory inspections.
• Maintain qualification, calibration status and lab documentation for analytical equipment.
• Contribute to operational excellence and continuous improvement initiatives.

Kenntnisse

GxP compliance

Data integrity

QC testing

Laboratory procedures

German-English

Ausbildung

Lab Technician or scientific degree

Bachelor/Master in Chemistry or related

Tools

Analytical equipment

Jobbeschreibung

Novartis is seeking a QC Specialist in Schaftenau, Austria, to support reliable laboratory operations, ensure GxP compliance, and review QC analyses. You will monitor testing activities, assist analysts, and contribute to audits and continuous improvement in a collaborative team.

The role requires strong GMP/GxP knowledge, lab experience, and fluency in German and English, with a focus on data integrity and regulatory documentation in a high-quality pharmaceutical environment.