Vidhya K. Email & Phone Number

Sugar Land, Texas, United States

Sugar Land, Texas, United States

🧪Created spreadsheets and other documentation to accurately record and calculate analytical results.🧪Initiated procedures and specifications to reflect current USP/EP monographs.🧪Calibrated and maintained all laboratory equipment, including spectrometers and chromatographs.🧪Updated documents to current GMP and FDA guidelines.🧪Led Final Finished product release testing team, Stability product testing, and Raw Material/API release.🧪Implemented trend analysis of the stability of creams, ointments, sprays, and gels.🧪 Initiated method development and technical transfer for both microbiology and pharmaceutical areas.🧪 Communicated analysis results to various departments and stakeholders to formulate productseffectively.🧪 Completed analysis of finished pharmaceutical products using various methods to test for purity.🧪Examined inoperative or malfunctioning production equipment to diagnose the source of trouble.🧪 Developed methodologies to identify contaminants, including multi-step process, aseptic/sterile intopical and inject able products.🧪 Performed standardized tests on organic and inorganic compounds to observe fundamental differences inproperties.🧪 Coordinated analytical tests to comply with established standards and specifications.

🧪Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.🧪Developed monthly, end-of-quarter, and other statistical reports for leadership team and qualityimprovement programs.🧪Integrated procedures for System suitability for SDS-PAGE electrophoresis and Iso-electric focusingassays and internal controls for HPLC assays.🧪Strengthened maintenance for HPLC for Quality and well Analytical Development environment.🧪Oversaw QA on the floor activities to support client’s projects such as auditing processes and reviewing documentation in real-time.🧪Facilitated GMP operations are about cGMP compliance.🧪Ensured adherence to internal procedures and industry best practices during manufacturing and support areas.🧪Updated SOPs to reflect the use of a validated spreadsheet for calculations vs. manual calculations.🧪Investigated all floor quality issues and provided immediate corrections.🧪Evaluated product stability used in clinical Phase I and Phase II trials via reports and trending analysis.🧪Procured equipment in the lab to improve efficiency, increase the time required to release materials for production, and increase electronic compliance.🧪Collaborated with project management and quality control to accomplish project deliverable.

👉Monitored employee performance and advised managers on necessary improvements to achieve targets.👉Communicated with warehouse team leader on carrier issues, STO information, and weekly productivitymetrics.👉Back filled coordinators work across shifts to maintain adequate coverage for operational needs.👉Enforced organizational standards to maintain a safe and healthy work environment.👉Helped keep inventory accurate by overseeing daily cycle counts.

Mba, Business Administration And Management, General

Ged