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SUN PHARMA
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Senior Executive - MSTG Orals

Senior Executive - MSTG Orals

SUN PHARMA

5 - 9 years

0 Lacs

halol gujarat

Posted:20 hours ago| Platform: Shine logo

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Skills Required

process qualification batch manufacturing risk assessment technology transfer stability testing change control regulatory audits compliance execution monitoring sampling protocols product history evaluation technical remediation product robustness improvement investigation reports out of specification oos out of trend oot corrective preventive actions capa planned deviations unplanned deviations product containment approaches risk assessments elemental impurities nitrosamine impurities residual solvents quality control testing statistical evaluations standard operating procedures sop training schedules

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: As a Manager-II in the MSTG department at Dadra, your primary responsibility will be to provide support in the execution and monitoring of trial, scale up, and exhibit process qualification batches. You will be involved in 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. Sharing process knowledge with cross-functional departments through presentations to facilitate smooth technology transfer will also be a key aspect of your role. Key Responsibilities: - Review and evaluate product history and process parameters for technical remediation and product robustness improvement. - 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. - Track activities related to change control, Corrective and Preventive Actions (CAPA), planned deviations, and unplanned deviations. - Prepare and review product containment approaches and risk assessments for new products, including risk assessment reports for elemental impurities, Nitrosamine impurities, and residual solvents. - Arrange placebos for quality control testing, change part development, and assess the feasibility of products. - Conduct statistical evaluations for process assessments, preparation and review of standard operating procedures, training schedules, and conducting training sessions. Qualifications Required: - Bachelor's degree in a related field (Chemical Engineering, Chemistry, Pharmaceutical Sciences, etc.). - X years of experience in a similar role within the pharmaceutical industry. - Strong understanding of regulatory requirements and quality standards. - Excellent communication and presentation skills. - Ability to collaborate with cross-functional teams and share process knowledge effectively. (Note: Any additional details about the company were not included in the provided job description.),

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Senior Executive - MSTG Orals