Summary
About the Role
Major accountabilities:
- Ensures compliance with cGxP, incl. data integrity on the Country Quality activities -Support exception investigations -Review and approval of product related quality topics - Support commercial area on launches and commercial needs -Involved on quality topics related product impact --Support OpEx improvement projects– Oversight batch release process in compliance with registration -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
- Support on-time and GMP-compliant release of dosage forms - On time launches support and no quality impact or delays -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects
Minimum Requirements:
Work Experience:
- Functional Breadth.
- QC/ QA in pharmaceutical ind./ biotech.
- Collaborating across boundaries.
- GMP and DI experience
Skills:
- Continuous Learning.
- Dealing With Ambiguity.
- GMP Process.
- QA (Quality Assurance).
- Quality Standards.
- Self Awareness.
- Technological Expertise.
- Technological Intelligence.
Languages :
- 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
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
