Sep 15, 2022

Job Description

80million! This is the number of products that are processed in our Production Site in Stein per year. As part of our Quality Control team, you will play a key role in analyzing and confirming the highest product quality for millions of patients in more than 150 countries around the world.

We are looking for a highly skilled & experienced laboratory professional who will contribute from Day 1 by performing analytical release testing, investigational support, research support, and stability testing.

Your main responsibilities:
• OOx/Deviation handling
• CAPA definition/ KPI trending
• Ensuring all activities are in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release)
• Stability testing (Projects)
• Review and approval of analytical tests (analytical release)
• Microbiological QC/ Perform Microbiological testing of materials and utilities, environmental & personnel monitoring
• Provide expert Support for site qualification & validation activities
• Maintain and calibrate equipment incl. plan preparation
• Support sample planning and sampling execution
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Qualification (IQ/OQ/PQ) of computerized analytical instruments
• Project work for the digitization of QC processes

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• 3-5years experience in Pharma/Manufacturing sector in analytical lab in a GMP environment/equivalent
• Quality Control (QC)/ Testing Quality Control Sampling
• Quality decision making
• Knowledge of IT Applications & tools
• Knowledge of TQM and related industry GxP standards and processes
• Fluent German, proficiency in English

Over 799 million! - that's how many lives we reached with our products in 2021. And while we are proud of this, we continuously ask ourselves the question: how can we improve and extend even more lives in a world of digital and technological change? We are convinced that we can find answers if curious, courageous and team-oriented people are encouraged to question the status quo, make courageous decisions and follow innovative paths.

*Some restrictions on flexible working options may apply and will be discussed during interview if applicable.

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Novartis Technical Operations
Stein (Säckingen)
Full Time
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QC Specialist II ( 80-100%)*

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