Quality Control Specialist II - GMP/GxP Expert (Austria)

Novartis; Österreich; On-site; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Modern company pension scheme

Childcare facilities

Learning and development opportunities

Worldwide career possibilities

Hybrid working options

14 weeks parental leave

Insurance plans

Retirement plans

Job summary

Novartis in Schaftenau, Austria, is seeking a QC Specialist to support reliable laboratory operations within the QCMD team, ensuring high quality standards. You will monitor testing activities, assist laboratory analysts, review QC analyses, and help manage deviations and investigations.

This role requires strong GMP/GxP knowledge and fluency in German and English, with a collaborative, solution‑oriented mindset. Onsite work is expected; relocation support is not available.

Qualifications

• Education as a Lab Technician or a university degree in a scientific/technical field.
• Experience in a pharmaceutical laboratory, QC, QA, analytics in GMP-regulated env.
• Strong knowledge of GMP, GxP standards, QC testing, QA and quality documentation.
• Understanding of laboratory equipment, analytical processes, data integrity, and compliance.
• Ability to manage ambiguity and support investigations, deviations, CAPAs and improvements.
• Good communication in German and English across QC, QA, production, AS&T, and teams.

Responsibilities

• Oversee production and testing activities to ensure compliance with cGxP, including data integrity and eCompliance requirements.
• Review and approve QC testing results, production documentation, QC records, and AS&T records.
• Support exception, deviation, and investigation processes with timely follow-up and documentation.
• Ensure QC activities are executed according to GMP, GxP, regulatory, and internal quality standards.
• Support batch release activities in compliance with GMP, registration, and license requirements.
• Contribute to audit and inspection readiness, including support during GxP audits and inspections.
• Ensure analytical equipment qualification, calibration status, and laboratory documentation are maintained.
• Support operational excellence and continuous improvement initiatives to improve quality, efficiency, cost, and delivery.

Skills

German language proficiency

English language proficiency

GMP/GxP knowledge

Quality control testing

Quality assurance documentation

Laboratory equipment understanding

Data integrity/compliance

Investigations and CAPA handling

Education

University degree in chemistry, pharmacy, biology or related field

Lab Technician qualification

Job description

Novartis in Schaftenau, Austria, is seeking a QC Specialist to support reliable laboratory operations within the QCMD team, ensuring high quality standards. You will monitor testing activities, assist laboratory analysts, review QC analyses, and help manage deviations and investigations.

This role requires strong GMP/GxP knowledge and fluency in German and English, with a collaborative, solution‑oriented mindset. Onsite work is expected; relocation support is not available.