Devendra Raghuwanshi Email & Phone Number

Responsible for Review of Analytical Method validation reports, method transfer reports and Method Verification data, reports and support for the regulatory submission.Review of Computer system validation (CSV) data of Quality control applicationsHandling of investigation of laboratory Incidences, OOC, OOS.Change controls, CAPA handling through QAMS. Review of Electronic data and Audit trails to ensure the data Attributable, Legible, Contemporaneous, Original and Accurate.Leading and Guiding of Analytical QualityReview of Protocols not limited to hold time protocol, Stability protocols, and review of stability summary sheets.Responsible for inspections in Quality Control Laboratories as per Schedule.

New Delhi, Delhi, India

Responsible for periodic self-inspections.Responsible to conduct the vendor Audits to monitoring the quality systems.Review of Electronic data and Audit trails to ensure the data Attributable, Legible, Contemporaneous, Original and Accurate.Review of the documents before submitting to Regulatory Affairs department for different filings like USFDA, CEP…etc. Creation and Implementation of Custom fields calculation formulas in Empower and sign off procedures in Quality Control Laboratory.Successfully faced regulatory audits (USFDA, TGA, MHRA, WHO & Vendor audits)

Responsible for Execution & Review of Analytical Method validation, method transfer and Verification Document and support for the regulatory submission.Response to conduct the Internal Audit.

Responsible to Execution of Instrument Qualification activities (IQ, OQ, PQ) & instrument calibration.Responsible for Maintenance of reference standard, primary standards, Responsible for CSV ( Computer system validation and Method validation of Elemental Impurities ( ICPMS).

Lean Six Sigma Green Belt, Cost Optimization

M.Sc, Applied Chemistry, First Division