Job Description

2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it\'s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role! Job Purpose : Provide quality services in compliance with cGMP requirements and Quality Management System as defined and agreed between QSC and business partners. Manage Quality aspects & projects within area of responsibility Major Accountabilities : Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows. Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, etc.) to ensure appropriate execution of service deliverables. Generate and analyze predefined and ad-hoc reports in various applications (like AQWA etc.) and perform follow-up actions if required. Bring up service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures. Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements. Support implementing service quality and process improvement projects, CAPA management within Quality Service Centers Responsible for the evaluation of chemical synthesis routes to identify, categorize and control possible mutagenic impurities in active pharmaceutical ingredients (API) and drug products. Assessment of potential degradation pathways of APIs in final drug products with the purpose to identify and assess possibility for the formation of potentially mutagenic impurities and ways to prevent this. Participate in cross- functional technical teams to deliver on projects. Involved in paper- based assessment of toxicological data for mutagenic, genotoxic and nitrosamines Conduct of feasibility studies for generic API synthesis and synthesis of by-products, degradation products and related substances. Protection of intellectual property in the field of organic synthesis. Utilize scientific expertise and chemical database to generate solutions to problems. Maintaining laboratory logbooks and other project documents in accordance with good documentation practice and HSE requirements. Co-ordination of laboratory work performed by technicians. 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. Minimum Requirements Post-Grad degree (MSc) in Chemistry, Pharmacy or other Natural Science degree with proficient program in organic chemistry with 6 years of relevant experience. Excellent theoretical knowledge of Organic chemistry and mechanisms of chemical reactions, advanced knowledge of medicinal chemistry advantageous. Proven record as a successful synthetic Organic Chemist and other complex synthetic chemistry experience. Experience in active pharmaceutical ingredient synthesis and PhD from the field of Organic or Medicinal chemistry. Excellent communication, presentation and interpersonal and analytical skills Experience of working closely with the global stakeholders. Project Management skills Division SANDOZ Business Unit Quality STO Country India 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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