QA Specialist Operations

vor 14 Stunden

Kundl, Österreich Novartis Vollzeit

**Summary**:
QA Specialist Operations manages quality aspects and projects within area of responsibility, ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.

This is a 50% part-time job.

**About the Role**:
**Major accountabilities**:

- Perform batch record review (BRR) and ensure timely, GMP-compliant batch release in alignment with regulatory requirements
- Oversee completeness and accuracy of production and QC documentation, including preparation of release packages
- Support exception investigations and resolve documentation gaps in collaboration with cross-functional teams
- Drive continuous improvement initiatives (OpEx), including process optimization and digitalization (e.g., transition to electronic batch records)
- Analyze recurring documentation issues and implement standardization measures to prevent errors
- Prepare for audits and inspections, ensuring compliance with cGxP and data integrity standards
- Actively participate in QA meetings to monitor progress, identify bottlenecks, and ensure on-time release
- Oversight of all production and testing activities ensures compliance with cGxP.

**Minimum Requirements**:

- Experience in Quality Assurance, Manufacturing, or a GMP-regulated environment, preferably within the pharmaceutical industry
- Experience with release processes, batch record review
- Familiarity with GMP regulations, audit preparation, and quality documentation
- Hands-on experience working with cross-functional teams (e.g., Manufacturing, QC, Engineering)
- Preferred: Experience with SAP, 1QEM, or other QA-relevant systems
- fluent German is required, English language desired

** Benefits and Rewards**:
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 59.781,96 /year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

We are open for part-time and job-sharing models and support flexible and remote working where possible.

** Commitment to Diversity and Inclusion / EEO paragraph**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

** Accessibility and Accommodation**:
** Why Novartis**:
Division

Operations

Business Unit

Universal Hierarchy Node

Location

Austria

Site

Kundl

Company / Legal Entity

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Functional Area

Quality

Job Type

Part time

Employment Type

Regular

Shift Work

No

**Adjustments for Applicants with Disabilities**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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