Summary -Manages Quality aspects and projects within area of responsibility -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems 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 Perform statistical data analysis to report Out of Expectations OOE out of trends OOT etc SAP master data management Maintenance of master data creation of Q-info records and other SAP related activities Validate spreadsheets Collect transcribe and or compile data from various repositories SAP LIMS external COAs Author approve and archive Impurity risk assessments - Nitrosamines residual solvents etc 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 sites Support regulatory requirements - routine queries Chromatogram requests Compile Quality performance management decks Create and review GxP documents including SOPs working procedures trend reports qualification reports and technical investigations as and when needed Key performance indicators On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects Minimum Requirements Pharmacy Science MBA 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 Good communication presentation and interpersonal skills Experience of working closely with the global stakeholders Skills Continuous Learning Dealing With Ambiguity Gmp Procedures Qa Quality Assurance Quality Control Qc Testing Quality Standards Self Awareness Technological Expertise Technological Intelligence Languages Fluent in English written and spoken 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 Perks 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 Division Operations Business Unit Other Location India Site Hyderabad Office Company Legal Entity IN10 FCRS IN010 Novartis Healthcare Private Limited Functional Area Quality Job Type Full time Employment Type Regular Shift Work No 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 Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve