Analytical R&D

As a member of the ARD Department, you will play a crucial role in ensuring the smooth daily operations of the analytical lab. Your responsibilities will include: - Developing, validating, and conducting routine testing of analytical methods. - Managing release and stability testing of raw materials, in-process, and finished products within specified timelines. - Creating validation protocols and reports in compliance with USFDA, EMA, and ICH guidelines. - Overseeing the calibration and maintenance of lab instruments according to established protocols. - Implementing Good Laboratory Practices (GLP) activities in the ARD lab. - Verifying all log books on a daily basis and preparing standard operating procedures. - Ensuring proper sample management and cleanliness within the lab. - Initiating and closing incidents, Variations in Reports (VIRs), and Change Controls. - Coordinating with vendors to address instrument-related issues and maintaining the qualifications of lab instruments. - Prioritizing development, validation, stability, and support analysis tasks. - Developing specifications, test methods, and standard testing procedures. - Assigning AR Numbers to testing samples and handling loading and withdrawal of stability samples as per protocols. Your role will be critical in maintaining the quality and efficiency of the analytical lab operations in the ARD Department. As a member of the ARD Department, you will play a crucial role in ensuring the smooth daily operations of the analytical lab. Your responsibilities will include: - Developing, validating, and conducting routine testing of analytical methods. - Managing release and stability testing of raw materials, in-process, and finished products within specified timelines. - Creating validation protocols and reports in compliance with USFDA, EMA, and ICH guidelines. - Overseeing the calibration and maintenance of lab instruments according to established protocols. - Implementing Good Laboratory Practices (GLP) activities in the ARD lab. - Verifying all log books on a daily basis and preparing standard operating procedures. - Ensuring proper sample management and cleanliness within the lab. - Initiating and closing incidents, Variations in Reports (VIRs), and Change Controls. - Coordinating with vendors to address instrument-related issues and maintaining the qualifications of lab instruments. - Prioritizing development, validation, stability, and support analysis tasks. - Developing specifications, test methods, and standard testing procedures. - Assigning AR Numbers to testing samples and handling loading and withdrawal of stability samples as per protocols. Your role will be critical in maintaining the quality and efficiency of the analytical lab operations in the ARD Department.