3 Nitrosamine Impurities Jobs

As a Manager-II in the MSTG department at Sun Pharmaceutical Industries Ltd, your primary responsibility will be to provide support for the execution and monitoring of trial, scale up, exhibit process qualification batches. You will be involved in preparing and reviewing new product documents such as material requirement sheet, master formula card, bill of material, master formula, risk assessment reports, sampling protocol, reports, exhibit batch manufacturing record, and exhibit protocols. Additionally, you will be required to prepare regulatory responses and share process knowledge with cross-functional departments through presentations for smooth technology transfer. You will play a key role in reviewing and evaluating product history and process parameters for technical remediation and improvement of product robustness. Your duties will also include preparing and submitting investigation reports for OOS, OOT, and any failure during exhibit/validation/commercial batch manufacturing and stability testing. Furthermore, you will be responsible for tracking activities related to change control, CAPA, planned deviations, unplanned deviations, and more. Your role will involve preparing and reviewing product containment approaches, risk assessment reports for new products, elemental impurities, Nitrosamine impurities, and residual solvent. You will also be tasked with arranging placebos for quality control testing, change part development, and evaluating the feasibility of products. Statistical evaluation for process assessment, preparation and review of standard operating procedures, training schedules, conducting training sessions, and participating in regulatory audits to support the plant will also be part of your responsibilities. Overall, as a Manager-II in the MSTG department, you will be at the forefront of ensuring the quality and compliance of processes and procedures while contributing to the continuous improvement and development of new products within the organization.,

Roles and Responsibilities Develop and validate analytical methods for Nitrosamines using LCMS techniques. Conduct method development activities such as instrument qualification, method validation, and sample analysis. Ensure compliance with regulatory requirements by maintaining accurate records of test results and reports. Collaborate with cross-functional teams to resolve issues related to method performance and data integrity. Provide technical support to production departments on method-related matters.

Interested candidate can directly mail their resumes at vishwaroop_goswami@baxter.com Research Associate III Nitrosamines (Characterization Team) - Team lead role Baxter Pharmaceuticals R&D is seeking a highly motivated scientist with proven expertise in liquid chromatography and mass spectrometry to join th Characterization team. As a catalyst within the Pharmaceuticals Global Business Unit, the successful candidate will apply state-of-the-art technologies in LC-MS and GC-MS in support of new and existing pharmaceutical products. The associate in this role will support Nitrosamine studies (core), extractables and leachable studies, using mass spectrometry-based approaches to identify nitrosamines, potential leachables from container extracts and develop and validate LC/MS methods to quantify NA impurities and leachable compounds in finished drug product solutions. What you'll be doing ! Develop, Validate and Transfer methods for quantitative determination of Nitrosamine impurities (Small Molecules and NDSRIs) at ppm to sub ppb levels. Involve in design of experiments for identification of root cause for formation of Nitrosamine impurities and developing mitigation strategies. Perform chemical extractions of container closure systems and drug product solutions in the laboratory. With the help of SME/Supervisor: plan, complete, and manage projects/programs that both span multiple fields and apply established methods, techniques, or approaches. Prepare technical feasibility of complex design concepts within area of expertise; recommend management regarding appropriate action. Interpret data, evaluate analytical results, identify trends/exceptions relative to product requirements, definitions, and/or project goals. Reach conclusions based on research analysis and incorporate recommendations into larger projects and share research outcomes and methodology with team members and other divisional personnel. Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development to ensure compliance in all research, data collection, and reporting activities. Maintain an in-depth knowledge and understanding of GxP and related regulations and guidance. Be able to provide insights into such regulations so as to facilitate efficient product registration. Be an active participant in the review, adoption, and interpretation of such regulations. What you'll bring ! Masters' degree or equivalent experience with at least 10-15 years, or PhD with 8-12 years in relevant field required. Skilled in carrying out sophisticated mass spectrometric experiments, such as accurate mass and MS/MS, and in the interpretation of mass spectrometric data. Must have good knowledge of organic chemistry and other analytical disciplines, such as chromatography, NMR, IR, etc. Advantage if possess skills, or demonstrated scientific background for the development of the vital skills, for the elucidation of unknown compound structure using a multidisciplinary approach. Experience in Nitrosamine, E&L testing/study design, environmental chemistry testing, and/or trace organic analysis preferred. Experience with complex method development and validation, particularly for quantitative LCMS methods, preferred. Experience working in a regulated pharmaceutical environment (e.g., cGXP) preferred