Senior Executive - MSTG Orals Sun Pharmaceutical Industries Ltd

5.0 - 10.0 years

0 Lacs

halol, gujarat

On-site

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.,

Posted 1 week ago

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Senior Executive - MSTG Orals SUN PHARMA

5.0 - 10.0 years

0 Lacs

halol, gujarat

On-site

The Manager-II in the MSTG department at Dadra is responsible for providing support in the execution and monitoring of trial, scale up, and exhibit process qualification batches. This includes preparing and reviewing new product documents such as material requirement sheets, master formula cards, bill of materials, risk assessment reports, sampling protocols, reports, exhibit batch manufacturing records, and exhibit protocols. Additionally, the role involves sharing process knowledge with cross-functional departments through presentations to facilitate smooth technology transfer. The Manager-II will also be involved in reviewing and evaluating product history and process parameters for technical remediation and product robustness improvement. They will prepare and submit investigation reports for Out of Specification (OOS), Out of Trend (OOT), and any failures during exhibit/validation/commercial batch manufacturing and stability testing. Tracking activities related to change control, Corrective and Preventive Actions (CAPA), planned deviations, and unplanned deviations is also part of the job responsibilities. Furthermore, the Manager-II will be responsible for preparing and reviewing product containment approaches and risk assessments for new products. This includes risk assessment reports for elemental impurities, Nitrosamine impurities, and residual solvents. The role also involves arranging placebos for quality control testing, change part development, and assessing the feasibility of products. Statistical evaluations for process assessments, preparation and review of standard operating procedures, training schedules, and conducting training sessions are also essential tasks. Lastly, the Manager-II will participate in various regulatory audits to support the plant and ensure compliance with regulatory requirements.,

Posted 1 week ago

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