May 18, 2022

Job Description

QC Specialist, Novartis, Stein, Switzerland

1! excellent opportunity to learn more about packaging material testing and the corresponding GMP processes. As QC Specialist you can have a significant impact on quality and customer service in the QC PM Team.

This role is limited for 24 months.

Your key responsibilities:

Your responsibilities include, but are not limited to:

• OOx/Deviation handling, CAPA definition, KPI trending; ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release) Stability
• Stability testing (Projects) – protocol preparation, evaluation, report preparation
• Reporting (Stability plan preparation, trend analysis, evaluation); Performance of Stability studies, protocols and comparative reports for supplier qualification
• 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 in supplier qualification; Trending and analysis of KPI/KQI; Support sample planning and sampling execution; Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Provide expert Support for introduction of computerized analytical systems (e.g. IQ/OQ/PQ)
• Participation and responsibility in/for digitization projects in the quality control area (e.g data integrity and efficiency improvement)

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

What you’ll bring to the role:

• 3 - 5years experience in Pharma/Manufacturing sector in analytical lab in a GMP environment
• Laboratory Excellence Laboratory equipment Quality Control (QC), Testing Quality, Control Sampling, Quality decision making experience
• Knowledge of IT Applications & tools as well as for analytical instrument qualification
• Knowledge of TQM and related industry
• GxP standards and processes
• Equivalent English desired

Why consider Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:

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

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Novartis Technical Operations
Stein (Säckingen)
Full Time
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QC Specialist

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