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QA Operations Expert
Responsible for QA release activities in context of raw material and consumables release. Handling of quality relevant events (DEV, OOx, complaints, etc.).
Major Accountabilities:
- Support monitoring, tracking and evaluation of the material release setup, contribute to the IIA KPI and RCI processes
- Lead and support DEV, OOx and complaint investigations and promote quality relevant topics and projects in scope
- Complete personal trainings in due course
- Ensure timely and compliant release of raw material & consumables, including: Make release decisions for raw material & consumables
- Oversee all non-conformity issues (OOS, OOE, OOT, deviations, complaints) related to raw materials released
- Drive consistent and efficient operation of the quality operations function in the area of responsibility
- Seek opportunities for productivity improvements, and coordinate their implementation
- Support to health authority inspections and customer audits
Minimum Requirements:
- Minimum bachelor degree or equivalent in life sciences or equivalent discipline (bioengineering, pharmacy, medical, biology, chemistry, etc.)
- Minimum 2 years of QC experience
- Knowledge of GMP and GDP standards and processes
- Risk Management and Quality Decision Making
- Required skills: Dealing with ambiguity, able to learn continuously, collaborating across boundaries and Change Management
- English and German language required
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Skills Desired
Collaboration, Communication Skills, Continuous Improvement mindset, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Problem Solving Skills, Regulatory Requirements knowledge
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