Summary
About the Role
Major accountabilities:
1. Handling of Audit CAPA actions, Deviations and Investigations.
2. Preparation of annual audit plans
3. Monitoring and maintain of KQI's and KPI's.2.
4. Maintenace of Shrepoints and Repositories. ·
5. Responsible to update the information on SharePoint/ trackers, review the applicable documents for correctness and archival of necessary documents on SharePoint. ·
6. Provide Administrative support in preparation of Quality Management Review meeting slide deck & metrics reporting. ·
7. Preparation, approval, and management of QAA's.
8. Develop and maintain process SOPs, working procedures and process maps. ·
9. Provide support for GMP External Audits and inspection management activities (HA and Self Inspection Audits).
10. Maintain Approved supplier list for GxP vendors.
11. Preparation of UQAP (Unified Quality Audit Program), Audit preparation support and QARP (Quality assurance responsible Person) Role for audit CAPA Management.
Minimum Requirements:
M.Pharm/ equivalent from a reputed institute.
• Min 4-6 yr Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances or products/ Medical device.
• Basic awareness of GxP compliance requirements.
Work Experience:
- QMS Knowledge w.r.t. deviations, Investigations, handling of CAPA.
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: 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
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
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
