Job Description

About The Role 1996! In this year Sandoz initiated the world\'s first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and world-class expertise and capabilities in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. This opportunity is waiting for you to contribute to Sandoz success story in the area of biosimilar toward the future, at the same time it becomes also the right step up in your career within clinical development! Your key responsibilities: Your responsibilities include, but not limited to: Ensure implementation of applicable Sandoz Quality Management System (QMS) requirements, with global and cross-functional teams. Support departments in identifying gaps/ deficiencies in the established quality management system that can independently trigger, investigate and implement the necessary corrective action in line with current external and internal standards to ensure continuous evolution of the quality system. Provide support in preparation, review and approval of GMP documents including local and global SOPs, WP\'s, Investigation reports etc., where required. Provide timely and effective communication of any potential compliance gaps/risks in Quality to the respective SPOCs or team lead and facilitate for resolution of identified gaps/ risks. Initiate, monitor and fulfill the timely review of APQR documents for all the ESO hubs/ Quality supports. Collect required data for the APQR preparation for preparation of summary reports. Create various KQI\'s/metrics for respective GxP activities for Quality for presenting in relevant forums. Ensure all time readiness of the activities for internal/ Business partner audits (including data integrity audits), host audits, and manage audit action plans for timely closure of agreed CAPAs. Conduct/support Self-inspections as per the approved Self-inspection plan for Quality, as required. Ensure predictive compliance by effective application of Quality Risk management and Quality Plan execution. Actively participate in enterprise-wide quality initiatives to increase the cultural awareness on Quality. Provide quality support to Nitrosamine risk based evaluation/ Changes required. Initiate and implement quality improvement/simplification projects within Quality, wherever possible. Impart trainings on GMP/Data integrity and other relevant trainings, as required. 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 What you\'ll bring to the role: Minimum 10 years of working experience in a pharmaceutical Quality Assurance or manufacturing, Quality Control, Supply chain. Profound knowledge of National/International pharma regulations. Exposure in implementing and continuously improving robust quality systems and processes, and maintaining global quality standards in regulated areas. Good knowledge of risk-based approaches in product lifecycle management Good communication and interpersonal skills. Professionalism and maturity required to effectively interact with senior management. Strong analytical, conceptual and problem solving skills. Excellent understanding of business processes, supply chain principles and practices as well as supporting systems and applications Good Project management skills and Change management skills. Good application knowledge (SAP, AQWA). In-depth GxP knowledge, Quality Risk Management, broad IT knowledge, continuous improvement Skills to deliver virtual and F2F Facilitation trainings. Provides pragmatic solutions to ensure compliance applicable regulations. Experience of working closely with the global stakeholders and negotiation skills. #orbit Why Sandoz 500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we\'re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world. How will we do this We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\'s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could achieve here at Sandoz! 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 [HIDDEN TEXT] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Join our Novartis Group 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 Division SANDOZ Business Unit Quality STO Work Location Hyderabad, AP Company/Legal Entity Sdz Pvt Ind Functional Area Quality Job Type Full Time Employment Type Regular Shift Work No Early Talent No

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