Ajeet Singh Rathore Email and Phone Number

• Responsible for compliance to standards, procedures and system, methods related to manufacturing, testing, storage and release of the marketed products at the respective external manufacturing site.• Responsible for review of operation and cleaning SOPs of critical equipment and instruments used for the product.• Responsible for process being run as per validated parameter for the product and review of process validation data.• Responsible for testing being performed as validated method for product under analysis and review of analytical validation data.• Review for microbial testing performed for the product and water/ Environmental monitoring sample verification.• Review of Qualification and calibration status of production/laboratory equipment used for the product in operation/Testing.• Review of training and qualification records of personnel involved in manufacturing and QC testing of product.• Review of stability analysis performed by the site for the product.• Periodic review of quality management system (Change control, Deviations, Out of specifications, incidents and market complaints).• Periodic review of Quality Management system for completeness of investigations to identify root cause, Existing controls available at site, Adequacy of proposed CAPA.• Participation in transfer process of new products to external manufacturing sites, by supervision of validation batches, review of related documents, and review of validation protocol and report. • Review of Quality trends, like Water trends, Environmental monitoring trends, review of all APQRs.• Release of products after complete review of certificate of analysis and random review of Batch manufacturing and packing records.• Ensuring the availability of current version of documents (MBRs, BPRs, Specifications, STPs, Datasheets, GTPs and SOPs.• Tracking of timely implementation of all CAPAs.• New location audits & CAPA.

Worked in Quality, Analysis, review and approval of Raw material, In process, finished Products and stability studies.