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 month ago

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