Shraddha Thakur Email and Phone Number

PV QA and Compliance

Global SME for Regulatory submission team and handling team resposible for submission to Regulatory agencies across US, EU, APaC regions. Performing RCA for late submission and including CAPA implementation/ effectiveness check. Part of core team to face Audit and Inspection as SME/Auditee. Workflow management and Capacity planning to ensure timely submission of cases globally. Leave management, SOP/WI maintenance. Leading sponsor governance meetings.

Preparation & revision of SOP's.Preparation of Master Formula Card (MFC) & Batch Manufacturing Record (BMR) for different dosage forms.Preparation of Batch Packing Record (BPR)Preparation of Stability protocol as per guideline.Preparation of Process validation protocol for different dosage forms

Sound knowledge in preparation of BMR, BPR, RM & FG Specification, training manual.Review of Validation protocol & reports, monitoring of Cleaning validation, Process validation & Analytical method validation.Maintain the quality systems such as: Change Control, Deviation Control, Out Of Specification, Out Of Calibration, Control Of Non-Conforming Products, CAPA, & Documentation Control.Releasing the Finished Products to the market & preparation of COA as per customers… Show more Sound knowledge in preparation of BMR, BPR, RM & FG Specification, training manual.Review of Validation protocol & reports, monitoring of Cleaning validation, Process validation & Analytical method validation.Maintain the quality systems such as: Change Control, Deviation Control, Out Of Specification, Out Of Calibration, Control Of Non-Conforming Products, CAPA, & Documentation Control.Releasing the Finished Products to the market & preparation of COA as per customers Specifications & Pharmacopoeias. Handling of customer complaints & handling of return & rejected goods.Monitoring the production activities & coordinate with production personnel to fulfill the documentation requirements. Monitoring & review of Qualification activities, review of DQ, IQ, OQ & PQ of instrument (such as FT-IR, UV-Vis etc), equipment & system such as water system, reactor, Blender, etc.Sound knowledge of ICH, GMP, GLP & cGMP practices.Document distribution & document control. Preparation of Standard Operating Procedures, logbooks & other documents. Show less