Sammendrag
About the Role
Manufacturing Systems Expert
Location - Hyderabad
About the Role:
Expert for the implementation of cGMP requirements in the manufacturing units, expert for plant qualification
Key Responsibilities:
- Operative support in various quality and GMP compliance aspects
- Acting as a flexible interface between individual manufacturing units and other departments such as Quality Assurance, MS&T, Engineering, Facility Management, etc.
- ensure compliance with local and global operating procedures and Novartis Quality Modules (QMs) relevant to the local quality system
- operational support of individual units in dealing with compliance issues (e.g. conducting deviation investigations, definition and implementation of CAPAs) and as coordinator in qualification projects
- Creating, reviewing and approving GMP-relevant documents such as risk assessments (RAs) or (validation/qualification-related) protocols and reports
- Creation and maintenance of general SOPs for DSK taking into account existing SOPs, QMs and guidelines
- Support in relation to current GMP compliance issues
- Participation in health authority inspections, GCA audits and self-inspections
Essential Requirements:
- Minimum 3-5 years of experience in Manufacturing / MS&T operations
- Fix-its/Turnarounds, Project Management, Collaborating across boundaries.
- Operations Management and Execution.
- Meet established validation milestones according to approved validation plans.
- Audit and inspection outcomes as a measure of validation compliance with global regulatory expectations.
- Timing and quality of technical reports.
- Timely and successful implementation of transfer activities (e.g. lab-to-lab transfer in launches).
Desirable Requirements:
- Academic Degree (PhD, MSc)
- Englisch: fluent in written and spoken language, German skills would be an advantage
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
