Prashant Desai Email & Phone Number

New Town Pa

Perform analysis of development samples, in process samples and R & D stability samples such as Tablets, Capsules and Oral Suspension.Provide analytical chemistry based method development support to formulation development and drug product development using standard platform such as HPLC/UPLC,TLC, KF, UV-Vis spectrophotometry,and Dissolution. Maintain and review lab notebooks and lab instruments logbooks.Calibrate and maintain laboratory instruments.Maintain lab with Good Housekeeping practice and in compliance with cGMPs.Train and Mentor new chemists.

Whippany Nj

Managing routine testing of incoming Raw Material, In-Process samples and Finished Products as per cGmps and current USP/NF.Review and approve release of Raw Material and Finished Products.Support production planning group for timely release of Raw Material and Finished Products.Updates testing methods for Raw Materials as per current USP/NF.Support validation group for IQ,PQ and OQ of lab instruments and process validation of the pharmaceutical products.Investigate OOS results, Aberrant results and implement CAPA.Maintain Training for the lab personnel as per SOP and cGMPs. Maintain safe environment for the labs and lab personnel following SOP and as per OSHA regulations.

Whippany Nj

Managing routine testing of incoming Raw Material, In-process samples and Finished Products as per cGMPs and current USP/NF. Review and approve release of raw materials and Finished Products.Updates testing methods for raw materials as per current USP/NF.Support validation group for IQ, PQ and OQ of lab instruments and process validation of the pharmaceutical products.Investigate OOS results, aberrant results and implement CAPA to close lab investigation.Maintain training of lab personnel as per site, division, corporate SOP and cGMPs.Maintain safe environment for the labs and lab personnel following OSHA regulations. Maintain Lab Supply and Good House keeping.Inventory of controlled substances and destruction of controlled substances.

Whippany Nj

Managing routine testing of incoming Raw Material, In-process samples and Finished Products as per cGMPs and current USP/NF.Managing timely testing of Stability samples.Review and approve release of Raw materials and Finished Products.Updates testing methods for raw materials as per current USP/NF.Investigate OOS results, OOT results, Aberrant results and Implement CAPA to close lab investigation.Maintain Training for the lab analysts as per SOP and cGMPs.Maintain safe environment for the lab and lab personnel as per SOP and OSHA regulations.

Whippany Nj

Supervise routine testing of incoming raw materials, in-process samples and Finished products as per cGMPs and current USP/NF.Review QC Data for compliance to test procedures, specifications and cGMPs.Approve release of Raw Materials and Finished Products in absence of Lab Manager.Train new analyst as per SOP and cGMPs.

Whippany

Perform testing of Raw Materials, in-process samples and Bulk Testing as per QC SOP and current USP/NF.Familiar with IR, UV, HPLC, Dissolution and wet chemistry.