2 Ich Q2R1 Jobs

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3.0 - 7.0 years

0 Lacs

neemrana, rajasthan

On-site

As a Validation Specialist at our company, your primary responsibility will be to plan, execute, and document analytical method validation activities for raw materials, in-process samples, finished products, and cleaning validation. This will involve assessing various parameters like accuracy, precision, specificity, linearity, robustness, LOD/LOQ, and others. You will also review and approve validation protocols and reports to ensure compliance with ICH Q2(R1), USP, and other regulatory standards, maintaining adherence to GMP, GLP, and cGMP guidelines. Your role will require collaboration with R&D, QA, and Production teams to facilitate seamless tech transfer and validation support. Trouble...

Posted 1 month ago

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3.0 - 7.0 years

0 Lacs

neemrana, rajasthan

On-site

You will be responsible for planning, executing, and documenting analytical method validation activities for raw materials, in-process samples, finished products, and cleaning validation. This includes assessing accuracy, precision, specificity, linearity, robustness, LOD/LOQ, and other parameters. You will review and approve validation protocols and reports in accordance with ICH Q2(R1), USP, and other regulatory standards to ensure compliance. Your role involves ensuring that all analytical method validation (AMV) activities adhere to GMP, GLP, and cGMP guidelines. Collaboration with R&D, QA, and Production teams is essential for seamless tech transfer and validation support. You will trou...

Posted 3 months ago

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