Nitesh Kumar Sen

Develop and execute all the start up plans for initiatives/projects/new

product

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• Execution of validation (IQ/OQ/PQ/IV/OV)

• Prepare and TT&T plan and execute it

To prepare RM Making instruction (MI), FOP & BOM as well as qualification of

RM.

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• To prepare safety study of RM material as per define region.

Input to develop GMC and responsible for keeping expenses within budget

for a project

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• Ensure compliance to all GSUM+ tools in all initiatives

• Lead/Support VAT plans for equipment's

• Develop RM/PM plans for the project and execute them

• Should have basic knowledge of ICH guidelines for healthcare products

• Should understand GMP requirements of WHO & USFDA

Trouble shoot the issues related to product, Process & systems on the

Making line

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Able to collaborate with RA and help in Dossier preparations for filing

formula & stability data

• 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.

Company Overview: Formally known as Wiscon Pharmaceutical Private

Limited

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• Oversee Quality Management System (QMS) at the corporate site

• Maintain and update the artwork database for approved country artworks

• Review and approve artwork

• Manage CAPA, QMS, and Change Control systems

• Handle document data control systems

• Prepare, review, and approve SOPs; maintain related records

• Revise SOPs and track training records as required

• Audit manufacturing sites as per the audit calendar

• Visit manufacturing sites based on product quality or country needs

• Review COA from contract labs/third parties and submit to DRA

Prepare and review product documents (licenses, GMP certificates, neutral

codes)

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• Create employee training calendars

• Manage vendor relationships, including SMF and agreement coordination

• Support daily activities as assigned by the manager

• 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.