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About the Role
Major accountabilities:
- Coordination and management of analytical method transfers and stability studies. Compilation of data reports
- Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints
- Work on various Labware LIMS workflows including various modules like Lot management, stability management, instrument interfacing, reagent management.
- Management of Master data in Labware LIMS and perform migration of LIMS records. Execute validation of configured workflows and calculations relevant to LIMS modules
- Perform test run/dry run in Labware LIMS for various workflows.
- SAP master data management: Maintenance of master data, creation of Q-info records and other SAP related activities.
- Collect, transcribe and/or compile data from various repositories (SAP, LIMS, external COAs)
- Trend and report all QMS elements as per the request
- Monitor, trend and report Health Safety and Environmental parameters
- Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules).
- Perform activities of a Quality Control expert as defined by the respective sit and support regulatory requirements – routine queries, Chromatogram requests
- Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed
Minimum Requirements:
- Pharmacy/ Science/ MBA / M.Tech/MSc /Engineering/ equivalent from a reputed institute
- Min 6 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices
- GxP knowledge, Basic IT knowledge
- Experience with LabWare LIMS application
- Good communication, presentation and interpersonal skills
- Experience of working closely with the global stakeholders
- Fluent in English (written and spoken)
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: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
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 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.
