Quality Assurance Operations Specialist (m/f/d)
Novartis · Kundl ·
- Employment
- Full time
- Category
- QA
- Company size
- 1000+
- Salary
- EUR 48,483 – 72,700 / year
QA Operations Specialist providing quality assurance support for drug substance manufacturing at Novartis in Kundl, focusing on batch record review, GMP compliance, and batch release.
Salary Range:
€48,483.00 - €72,700.00
Job Description Summary
#LI-OnsiteLocation: Kundl, Austria
The QA Operations Specialist is responsible for providing quality assurance support for drug substance manufacturing activities, with a strong focus on batch record review and GMP compliance. The role ensures timely and compliant batch release, supports investigations and audits, and contributes to maintaining the Novartis Quality Management System.
Job Description
Key Responsibilities
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
Obligatory requirements:
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
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 € 47.532,24/year (on a full-time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB
Skills Desired
Collaboration, Communication, Data Integrity, Data Monitoring, Deadline Management, Good Manufacturing Practices (GMP), Health Safety Regulations, Process Control, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Inspections, Statistical Process Control (SPC)