摘要
About the Role
Key Responsibilities:
• Comply with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes.
• Assist the department with any other ad hoc activities/ requests to meet the business requirements.
• Focus on timely completion of all relevant and assigned trainings.
• Learn, develop & leverage data and digital tools to build understanding and generate insights that support quality operations and decision-making as needed.
• Ensure responsibility and ownership of the assigned tasks and comply with accuracy and timeliness of deliverables.
• Comply to the applicable Novartis operating procedures as per legal/ IT/ P&O requirements
• Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed.
• Provide active support during internal and external audits by collecting and presenting the requested process/ data and reports.
• Adherence to the current GxP and compliance policies of Novartis Perform and deliver Quality Operations in support of product quality compliance and regulatory workflows.
• Hold accounts in workflow applications to ensure appropriate execution of process deliverables, using approved enterprise platforms as applicable.
• Escalate process related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures.
• Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements and any filed product quality standards.
• Engage regularly with business partners to gather feedback on the support provided and deliverables, ensuring continuous improvement and alignment with operational needs.
• Support the Master Data Management to the required sites as needed.
• Manage various types of change controls (e.g., Product, Asset, and others) using Novartis-approved digital platforms from initiation to closure, as applicable.
• Generate and analyze predefined and ad-hoc reports using authorized enterprise applications and perform follow-up actions as needed.
• Perform designated roles such as Entity Data Manager, Business Approver, P31 Module Approver, CRB Facilitator, Key User, and NCQ Non-Duplication Activity, based on business requirements.
• Provide governance support as needed.
• Execute service transition activities in accordance with established procedures.
Essential Requirements:
• Stakeholder satisfaction
• Proper handling of Change Controls as per the responsibilities delegated by the assigned entity
• Efficiency and Productivity Metrics
• Process improvements
• Compliance metrics
Desirable Requirements:
Work Experience:
• Stakeholder Management
• Project co-ordination
• Proficient in utilizing various enterprise tools and platforms to support quality operations and change control processes, including but not limited to workflow, reporting, and data management systems.
• Proficiency in MS Office tools
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: 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.
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.
