Job Description

About The Role 2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, passionate organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally! Together we will shape the future of Sandoz are you ready to make a difference 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. Key Responsibilities Responsible for authoring Step 1 Nitrosamine Risk Assessment reports (Medicinal Product summary report evaluating the potential risk of medicinal products containing chemically synthesized APIs for N-nitrosamine Impurities) Responsible for authoring Step 2 Nitrosamine Risk Assessment reports (Step 2 Medicinal Product conclusion report assessing the risk of medicinal products containing chemically synthesized or herbal APIs for N-nitrosamine Impurities Responsible for Review and Approval of Step 1 Nitrosamine Risk Assessment reports (Medicinal Product summary report evaluating the potential risk of medicinal products containing chemically synthesized APIs for N-nitrosamine Impurities) Responsible for Review and Approval of Step 2 Nitrosamine Risk Assessment reports (Step 2 Medicinal Product conclusion report assessing the risk of medicinal products containing chemically synthesized or herbal APIs for N-nitrosamine Impurities Responsible for archival of approved Step 1 and Step 2 Nitrosamine risk assessment reports. Support on preparation of cover sheets and templates for the risk assessment reports. Delivery of assigned initiatives in accordance with the approved project plan. Ensure availability of risk assessment reports as per the regulatory requirements in compliance with respective current guidance. Participate in cross- functional technical teams as required to deliver on projects. Creation of relevant instructions, protocols and reports in accordance with scientific and regulatory standards. Other tasks as assigned by the supervisor and tasks based on a specific appointment. Implementation of and adherence to all the instructions and requirements for safe work, environment protection and property protection. Responsibility for personal and professional development, willingness to continuously learn and enhance the knowledge. Continued education and learning in form of training and mentoring. High integrity and proactive cooperation within local and global teams across different geographies. If needed, to be trained according to SOPs related to GxP. 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 harmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute Min 4 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices GxP knowledge, Basic IT knowledge Fluent in English (written and spoken) Good communication, presentation and interpersonal skills. Experience of working closely with the global stakeholders 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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