Nitesh Kumar Sen

• Responsible for Vendor Management activities.
• Responsible for Preparation/Updating/Revision of Approved Vendor List for RM/PM/MM.
• Coordinate with user department or designee during quality issue of Incoming RAW Material/Packaging Material/Miscellaneous Material.
• Responsible for Evaluation of Vendor Documents and maintain Current Status of Vendors.
• Responsible to assist for creation of RM/PM Change Control, risk assessment, deviation and CAPA in caliber QMS.
• Verification of qualification documents received from Contract laboratories.
• Handling QA related activities in project stage
• To review the documents related to Contract Service (i.e. Validation/Qualification services ect.) along with that prepare Contract Service Agreement CG & CA.
• Verification & Review of COA, Specification, MOA, IP & FP received from analytical department/QC
• Responsible for providing required documents of Vendor to Cross functional team.
• Responsible for submission of the vendor samples to QC and maintain log of Sample Register.
• To prepare/maintain Vendor Qualification Report.
• Responsible for submission of the vendor samples to QC and maintain log of Sample Register.
• To handle/maintain the incoming material complaint notification from/logbook.
• Preparation/Revision of SOP’s related to Vendor Management/Vendor Qualification activity.

• Responsible to assist for create & update of Raw Material & Packing Material Vendors in SAP.
• To maintain quality agreements with manufacturers and contract manufacturing parties.
• Responsible for Vendor Management activity.
• Handling QA related activities in project stage.
• Responsible for Evaluation of Vendor Documents and maintain Current Status.
• To assist for preparing Vendor Grading of RM/PM based on Rejection of Supply from Vendors on Yearly Basis.
• Responsible for providing required documents of Vendor to Cross functional team.
• Responsible for transfer of RM/PM stock in SAP, due to On-line Rejection of it.
• Responsible for submission of the vendor samples to QC and maintain log of Sample Register.
• Responsible for intimation of RM/PM Rejection to purchase Department for CAPA and Maintenance of RM/PM rejection Tracking Sheet.
• Responsible for prepared & update approved Vendor list RM/PM.
• Responsible to assist for creation of RM/PM Change Control.
• Responsible to assist for create & update of Raw Material &Packing Material Vendors in SAP.
• To maintain quality agreements with manufacturers and contract manufacturing parties.
• Review of excipient risk assessments.

• Creation of technical documents like;
• Incoming material specification (PMP, MPMP)
• Bill of material (BOM) for Finished Good,
• Packing Instruction
• Standards of batch packing record
• To assist for any other jobs assigned from time to time.

CGPA: 6.98 (Passed with First Class)

• Completed professional development in Quality Assurance Department.
• Received [Scholarship - DOSJE]
• Awarded ( Mr. Hiphop)

Passed with First Grade

• Received [Scholarship DOSJE]