Tushar Khairnar Email and Phone Number

To Performed Vendor Audits, Audit Compliance, Handling of QMS activity through Trackwise Change Control, Deviation, CAPA, Investigation, OOS, Market Complaints, To Performed PAS-X Activity of eBMR & eBPR on shop floor, To review and approved of Validation & Qualification Protocol and reports for Equipment's and Instrument through Validator Software, To issued & archived the all GMP documents through Document Management System (DMS_PharmaReady), To complete Green Field Project.Computer System Validation Activity (CSV), GAMP 5.

Vendor Audits, Audit Compliance, Internal Audits, QMS Activity, To Review Master Documents received from CMO Site, Review of comments regarding Noncompliance from CMO and obtain comments from internal stack holders. Reviewed Manufacturing Compliance Documents (MCD). Involved in various quality improment project driven by company. To Reviewed and approved the Regulatory Affairs. submition documents.

Preparation of MFR, Handling of Deviation, Change Control, Looking of GLP Activity, Handling of Qualification activity for F&D.

Artwork reviewing and approval for Label, Leaflet & Cartons, Reviewing of Master BMR/BPR, Handling of Qualification activity for Equipment's and Instrument for Manufacturing and Quality Control Department, APQR Preparation, Handling of QMS activity like Market Completes, Deviations, Change Control, OOS/OOT investigation. To Reviewed and approved the Regulatory Affairs. submition documents.

Handling of Lab- QA Activity like Reviewing of Analytical Data Sheet, COA Reviewing and approval, Analytical Date reviewing in LIMS, Stability section In-charge, Handling of OOS/OOT, Lab Incidence Investigation, Handling of Trackwise software for QMS activity, Audit Trail Reviewing of Quality Control Instruments, Handling of documentation work, Preparation of PQR (Product Quality Reviewing) of various regulatory markets, To performed Internal Audits.