Asst Manager# #ADL#
Education : Msc (Chemistry) / M.PharmExperience : 12-17 Years
Job Profile :
*To review all DMF (API and Excipients tech pack) and send queries to purchase team for ARD requirement.
*To Plan daily work allocation to ARD associates and review all raw data/LNB for ROW, DCGI and regulatory projects.
*To compile all results and discuss to manager and FRD team.
*To attain the weekly projects, review meeting and to plan the activities accordingly.
*To review all STP, SPC, SOP, Lab STP, VSTP etc. of ROW, DCGI and regulatory projects.
*To plan the calibration, PM and review all respective raw data as per schedule.
*To Prepare Indents for Laboratory requirement and follow- up with purchase department and vendor. To attain weekly purchase meeting and maintain the record.
*To maintain TRF entries of FRD samples.
*To maintain and review VQ, verification and risk assessment record for all API’s and Excipients.
*To maintain and plan external lab testing and review the data for the same.
*To co-ordinate all internal department to complete the ARD activities on time.
*To guide to associate for daily GLP activities and method development activities of all ROW, DCGI and regulatory projects.
*Analysis of routine and Stability samples (Formulations, API’s, and Excipients)
*Development of Analytical methods like Assay, RS and Dissolution.
*Able to handle Team
Interested Candidates can apply on admin.rndmumbai@akums.in
