Specialist Job in Novartis
Job Summary
Job Purpose:
Provide Quality Service in compliance with cGMP regulatory requirements and the Novartis Pharma Quality Manual and Policies by implementing processes, systems and tools that realize the Quality Operations services across Novartis divisions.
Your responsibilities include, but not limited to
Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows.
Hold accounts in workflow applications (like SAP, Dragon, SUBWAY, TEDI etc.) to ensure appropriate execution of service deliverables.
Escalate service 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, filed product quality standards and service level agreements.
Support implementing service quality and process improvement projects, CAPA management within Quality Service Centers.
Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes. Assist the department on any other ad hoc administrative activities as per business requirements.
Regularly communicate with customers and partners to collect feedbacks on support services, report deliverable.
Min 3yr Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/Medical device.
GxP-knowledge, Broad IT-knowledge
Fluent in English (written and spoken)
Good communication, presentation and interpersonal skills. Experience of working closely with the global stakeholders
Why consider Novartis?
799 million. Thats how many lives our products touched in 2019. And while were proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more peoples lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where youre given opportunities to explore the power of digital and data. Where youre empowered to risk failure by taking smart risks, and where youre surrounded by people who share your determination to tackle the worlds toughest medical challenges.
Imagine what you could do at Novartis! Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Job Description
28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.Job Purpose:
Provide Quality Service in compliance with cGMP regulatory requirements and the Novartis Pharma Quality Manual and Policies by implementing processes, systems and tools that realize the Quality Operations services across Novartis divisions.
Your responsibilities include, but not limited to
Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows.
Hold accounts in workflow applications (like SAP, Dragon, SUBWAY, TEDI etc.) to ensure appropriate execution of service deliverables.
Escalate service 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, filed product quality standards and service level agreements.
Support implementing service quality and process improvement projects, CAPA management within Quality Service Centers.
Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes. Assist the department on any other ad hoc administrative activities as per business requirements.
Regularly communicate with customers and partners to collect feedbacks on support services, report deliverable.
Minimum requirements
M.Pharm/ MBA / Engineering/equivalent from a reputed institute.Min 3yr Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/Medical device.
GxP-knowledge, Broad IT-knowledge
Fluent in English (written and spoken)
Good communication, presentation and interpersonal skills. Experience of working closely with the global stakeholders
Why consider Novartis?
799 million. Thats how many lives our products touched in 2019. And while were proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more peoples lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where youre given opportunities to explore the power of digital and data. Where youre empowered to risk failure by taking smart risks, and where youre surrounded by people who share your determination to tackle the worlds toughest medical challenges.
Imagine what you could do at Novartis! Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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