Summary
About the Role
Position Title : ESO Change Coordinator
Location – Hyderabad, India
About the Role:
To support and ensure consistency and implementation of assigned Third Parties change projects from initiation to execution end to end, in order to ensure timely implementation of changes and supply to the markets in compliance with regulatory and cGMP requirements.
Key Responsibilities:
• Accountable for the inter-functional evaluation and implementation phases of change requests, considering the most effective implementation strategy, cGMP’s, regulatory requirements, Corporate Quality Manual, Novartis policies and cost effectiveness. Set priorities for change requests in line with the relevant boards.
• To support project teams in order to ensure project management according to the agreed strategy and timelines
• To ensure efficient, timely and clear communication to all involved partners (on-site and off- site incl. to global product lifecycle leader and RA CMC) as required for flawless project execution in collaboration with project leader
• To communicate project progress and deviations as appropriate in collaboration with project leader, when available. To elaborate risk mitigation plans as appropriate in collaboration with project leader
• To solicit input from site functions and to ensure that site specific information is made available in global projects and in relevant databases
• Needs to ensure that assessment of supply is performed
• To support process experts in evaluation, planning and execution for main and sub processes (e.g. CAR, capacity planning, resources, etc.)
• Actively participate in the decision making process whether a change has cross-divisional impact or not.
Commitment to Diversity & Inclusion: :
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements :
Essential Requirements:
• A minimum of 5 years of experience in regulatory environment, production, or lab.
• Experience in production/QA/QC is a beneficial advantage
• Excellent spoken and written English
Desirable Requirements:
• University or academic degree in Chemistry, Biology, Pharmacy or equivalent
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
