Successfully coordinated for USFDA and TGA Audits.
Review and Submission of relevant documents related to Drug Products for USFDA and other Regulatory authorities.
Done the Empower audit trail report as an attachment of review the audit trail. * New product launches as per time lines.
5'S Implementation in Quality control department.
Responsible to conduct periodic trainings on relevant SOP's & pharmacopeia updations.
Active involvement in the US FDA audit in Granules India bulk unit.
Responsible for overall activities of the inprocess samples; Process validation samples;
finished product samples & cleaning validation samples and Execution of Exhibit batches.
Process validation Protocols review and Approvals.
Closing of OOS, OOT & incidents with probable route cause.
Review of Standard Operating procedures, Specifications, Standard Test Procedures.
Responsible for maintain the Good laboratory practices in Quality Control.
Responsible for Transfer of Analytical Test Method from R&D to QC and for drug products.
Responsible for Instrument Calibration.
Review of Process Validation and Cleaning Validation Documents.
Responsible to the IQ, OQ & PQ of Laboratory instruments & Equipments.