Summary
About the Role
Major accountabilities:
- Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.
- Prepare, review and check the batch documentation for correctness, completeness and safely archive the original documents for the prescribed period and plan, conduct and monitor self-Inspection schemes for all sections.
- Ensure that all drug products are released to the market in accordance with the registered specifications and with local/international regulations.
- Escalate any issues or instances of instability per the Novartis escalation policy, and initiate any market action that is required.
- Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance and maintain access to regulatory and Pharmaceutical authorities in respect to up-dated GxP ovide latest know how in the field of GxP and other quality related fields.
- Establish and maintain cross-functional contacts with peer organization -Support launches of product in close collaboration with BD&L partner and/ or development organization.
- Ensure that Change requests are managed according to the Novartis SOPs from receipt, through to the implementation and closure.
- Archive relative documentations and manage/Approve critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual.
Obligatory requirements:
- Education: Pharmacy, Biotechnologist, or any other health care degree.
- 5+ years of experience in Quality Assurance, Quality Control and/or Manufacturing Operations,
- Solid knowledge of GMP regulations.
- Fluent English and Spanish, written and spoken.
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 tru ste d 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: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits rewards
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 an d o ur 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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
