Senior Executive - MSTG Orals Sun Pharmaceutical Industries Ltd
Sun Pharmaceutical Industries Ltd
Office Location
Full Time
Experience: 5 - 5 years required
Pay:
Salary Information not included
Type: Full Time
Location: Gujarat
Skills: scale up, risk assessment, Technology transfer, change control, CAPA, Standard operating procedures, Training, Regulatory Audits, Execution, monitoring of trial, Process qualification batches, Preparation, review of new product documents, Sampling protocol, Regulatory response, Product history evaluation, Process parameters evaluation, Investigation report preparation, Regulatory evaluation, Planned deviations, Unplanned deviations, Product containment approach, Risk assessment for new product, Elemental impurities, Nitrosamine impurities, Residual solvent, Placebo arrangement, Quality control testing, Statistical evaluation
About Sun Pharmaceutical Industries Ltd
Job Description
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.,