Summary
#LI-Hybrid
About the Role
Key Responsibilities:
- Implementation and improvement of the quality management system (QMS)
- Monitoring and interpretation of up-to-date requirements of GxP as well as requirements of the pharmaceutical law with regards to products imported and distributed
- Ensure that all aspects of the importing and distributing of products in the country align with the requirements of the Novartis Quality Manual and local legislation
- Conduct Audits covered processes and procedures in GDP/GMP
- Supervision and processing of deviations
- Monitoring and overseeing quality incidents/deviations. Performing investigation and identification of a root cause of deviations, including analyzing trends of detected deviations
- Monitoring the correctness of implementation and effectiveness of the introduced CAPA. Ensure all required actions are taken appropriately and in a timely fashion
- Participating in the work of the Risk Assessment Team and the Validation Team
- Implementing and maintaining a change control in the QMS
- Plan, initiate and monitor basic GxP-training for all employees in regular intervals
Essential Requirements:
- Minimum of 2-3 years of experience in quality assurance
- Native Polish language
- Advanced proficiency in English
- Above-average proficiency in Excel
Desirable Requirements:
- Experience acting as a Qualified Person
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
You’ll receive:
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), employment at Top SI Employer, Unlimited learning and development opportunities.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work 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
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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.
