4 - 8 years

0 Lacs

Posted:1 day ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: You will be joining Syngene International Ltd. as a Senior Executive 9-II in the Quality Assurance department at the Mangaluru location. Your main responsibility will be to provide in-process Quality Assurance support for executing GMP manufacturing activities at the Mangalore manufacturing facilities. You will ensure that the Site Quality system is always in compliance and ready for Regulatory & Client inspections by following all necessary quality procedures. Additionally, you will handle change controls, deviations, CAPAs, and assure online documentation integrity. Key Responsibilities: - Provide In-process Quality Assurance support for GMP manufacturing activities - Ensure compliance of Site Quality system for Regulatory & Client inspections - Support IPQA for product changeover, Manufacturing, Packing, and maintenance activities - Handle change controls, deviations, and CAPAs - Review Batch Manufacturing Records, Specifications, SOPs, Validation documents, and other quality documents - Perform regular review of logbooks for compliance - Evaluate cross deployment CAPAs, 483s, and Regulatory surveillance - Support Vendor management process Qualification Required: - Educational Qualification: B.Tech/M.Tech/ M.Sc. in Chemistry - Experience: Minimum 4 to 8 years of Pharma experience in API, QMS, Investigations, etc. - Technical Skills: Experience in handling quality assurance activities in a manufacturing environment - Behavioural Skills: Dedication to work, result-oriented approach, self-driven, and team coordination - Software Skills: Proficiency in Trackwise, EDMS, and SAP Please note that Syngene International Ltd. is an Equal Opportunity Employer.,

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