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10.0 - 15.0 years
0 Lacs
karnataka
On-site
As a Manager Quality Assurance at Syngene International Ltd., you will be responsible for ensuring compliance with all national and international regulatory agency requirements related to API manufacturing. Your role will involve evaluating and approving vendors/subcontractors, reviewing and approving various reports such as SOP, analytical method validation, and calibration reports, and coordinating review meetings to maintain the effectiveness of the quality system. You will be expected to have a strong understanding of regulatory requirements from agencies such as ICH, USFDA, WHO Geneva, PMDA Japan, and others. Additionally, you will play a key role in the approval of protocols and report...
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
navi mumbai, maharashtra
On-site
You will be responsible for preparing and updating QMS documents such as manuals, procedures, work instructions, and forms to ensure that all processes at OSSI workshop comply with applicable standards. You will communicate QMS requirements and updates to the affected functions and provide training when necessary. Conducting internal audits as per the yearly plan and coordinating Management Review Meetings for OSSI workshops will also be part of your role. Your duties will include initiating actions to minimize nonconformities, promoting awareness of customer requirements, and executing recovery plans to improve quality performance if needed. You will coordinate API and customer audits, ensu...
Posted 2 months ago
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