Résumé
About the Role
Major accountabilities:
- Drafting of Annual Monitoring and Certification report for incoming materials.
- Drafting / Negotiation (if applicable) and Archival of Quality Assurance Agreement with Suppliers/Service providers.
- Evaluation and Management of Supplier Change Notifications (SCN) and Initiation of quality record for the applicable SCN.
- Drafting and Evaluation of Supplier’s incoming materials Specification.
- Performing Quality Risk Assessment (QRA) for existing and new Suppliers / Service providers.
- Management of Supplier/ Material qualification and supplier related documentation.
- Preparation of regulatory statement for materials and finished products.
- Management Quality records, Support the Service Delivery team (SDT) with quality topics and 3rdPAP Management in TPRM (Third Party Risk Management) tool.
- Coordination with stakeholders in SIM (Supplier Information Management) approval process for Quality deliverables.
- Preparation of relevant contributing report for respective APQR section.
- Evaluation of change control tasks/ deviations related to supplier quality management.
- Audit preparation support, QARP and FURP Role for audit and CAPA Management.
- Responsible for the Functional representative activities.
- End to end deliverables for supplier / Vendor quality management activities as per the delegated task from the business partner.
Obligatory requirements:
- Education: M. Pharma / B Pharma / MSc or Equivalent from Reputed university.
- Experience: 8 Years of pharmaceutical Quality experience preferably in Supplier Quality Management area.
- Basic Project management skills
- English fluent, 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 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
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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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.
