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8.0 - 11.0 years
18 - 20 Lacs
navi mumbai
Work from Office
Role & responsibilities Will be a part of R&D Biotech team The role involves supporting product development and ensuring compliance with global regulatory standards. Should have a thorough understanding of biosimilar CMC aspects- process and analytics Should be updated with latest developments in various regulatory guidelines related to CMC across geographies (RoW, EMA, ANVISA, USFDA, PMDA etc) Will be responsible to provide technical support for regulatory queries for product registration and variation filings. Authoring of query responses related to product characterization and process/ product development Preparation of technical justifications/declaration to support regulatory submission...
Posted 1 day ago
2.0 - 6.0 years
0 Lacs
ankleshwar, gujarat
On-site
As an Executive at Zydus Lifesciences, Ankleshwar unit - 2 in Technology Transfer, your role involves the following responsibilities: - Identifying process criticalities, equipment mapping comparison from site to site etc. w.r.t. Scale-up. - Managing for making EHS friendly process. - Engaging in detailed discussions & finalizing the process for all site transfer molecules. - Coordinating with the team for equipment mapping at the plant for site transfer molecules. - Planning, coordinating, and effectively communicating for the execution of products at the plant. - Checking and approving from TT side on trial reports. - Exploring new technologies and implementing them at the plant. - Schedul...
Posted 2 months ago
6.0 - 10.0 years
0 Lacs
pune, maharashtra
On-site
Role Overview: As a Design Review Engineer, your role will involve reviewing product designs and providing feedback to designers to ensure compliance with standards such as UL, CSA, FM, ATEX, IEC, NEC, and others. You will also be responsible for assessing schematic and PCB designs, identifying non-compliance gaps, and working with the design team to address issues. Additionally, you will evaluate drawings, manuals, and reports to ensure they meet the required standards. Key Responsibilities: - Review product designs for compliance with industry standards - Evaluate schematic and PCB designs to ensure they meet IS requirements - Identify non-compliance gaps and collaborate with the design te...
Posted 3 months ago
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