Senior Quality Assurance Operations Specialist

Job Description Summary

The Senior 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

This position is a temporary, activity‑based role and is limited to a fixed term of two years.

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:

• Education: Master's degree - Other (e.g., MSc) in Microbiology.
• 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 and English

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? https://www.novartis.com/about/strategy/people-and-culture

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 Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge