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About the Role
Major Accountabilities:
- Ensuring PCS compliance with training records, CV, and JDs.
- Ensure all documentation is consistent with GLP requirements.
- Support periodic review and maintenance of PCS SOPs.
- Maintain good working knowledge of any company SOPs that influence or impact the PCS SOPs.
- Get necessary input/feedback from relevant stakeholders to keep documentations up-to-date·
- Create and perform quality checks on SEND packages for FDA submissions
- Support electronic laboratory notebook compliance ensuring the necessary reviews and compliance with company guidelines
- Support the Study Quality and Compliance team’s effort for tracking and managing study-related information in a global online fashion by leveraging the use of software tools to enhance productivity and information sharing.
Minimum Requirements:
- Graduate/ Postgraduate in Life Sciences with 10-15 years relevant experience working in pharmaceutical GLP setting.
- Good working knowledge of regulatory compliance requirements
- Knowledge of animal welfare requirements related to study conduct
- Previous experience creating and reviewing SEND packages
- Good communication skills, and excellent logistical/planning skills
- Previous experience with software for online information and program management is a plus
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)
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 diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
