Vishnu Hawale

Leading and managing Out of Specification (OOS), Out of
Trend (OOT), laboratory incidents, CAPA, FDA compliance
issues, and investigating discrepancies in depth to identify the
root cause.  Excellence in implementation of CAPA action and QMS
activities.  To performed the RCA (root cause analysis) depth in
investigation.  Leading the team of Analytical Method validation/Verification
and method transfer.  Expertise in performing and handling of team for Analytical
Method transfer and method validation/Verification and
working standard Qualification.  Proficient in analytical method validation, verification, and
transfer for finished products, in-process materials, and
stability studies  Supported to transition from paper based to paperless QC lab
by using Caliber ELIMS and other software.  Quality Risk Management /FMEA and Risk mitigation  Comprehensive knowledge of analysis of finished product,
stability samples as per ICH and regulatory requirement.  Reviewed working standards, raw materials, finished
products, stability study samples, and chromatographic data
integration, including troubleshooting related issues.  Developing & submitting necessary monthly quality control
reports to top management for facilitating decision-making.  Expertise in mentoring teams for enhancing process
efficiency.  Maintained the TAT (Turn around time) to increased the
productivity by using of paperless lab flow.  To present and attend the QMR monthly basis with higher
management for closure of QMS document within time frame.  Involving the monthly basis CFT audit for other location for
QC laboratory.  Regulatory professional with knowledge of FDA 21 CFR Part.