DEEKSHA P R

· Proficient in preparing, reviewing, and optimizing scientific and

technical validation documents.

· Handling of Documentation and Validation Activities.

· Preparation of Specifications & Methods of Analysis (MOA).

· Preparation of dispatched material COA.

· Issuance and review of BMR, BPR, and other documents.

· Review and Preparation of Standard operating procedure and

standard testing procedure.

· Handling of Deviations / Change Control / OOS (Out of

specification) / Investigation/Recall.

· Handling Market complaints and their compliance.

· Responsible for collection/compilation of data and conducting

monthly Management review meetings (MRM) and Internal

audits.

· Review and approval of protocols & Reports of Stability study,

Environmental monitoring.

· Approval of vendor questionnaires and quality agreements.

· Review of calibration certificates and preventive maintenance

documents.

· Preparation of corrective and preventive actions (CAPA) for

observations made in internal and external audits.

Audit Exposure:

Knowledge of 21 CFR Part 117 USFDA audit, HALAL audit,

FSSC 22000 Ver 6 , Kosher audit

· Daily Calibration of Laboratory equipment like Analytical

Balances, pH meter

· Wet Lab Analysis of Herbal Extracts for measuring their pH, Total

dissolved solids, Loss on Drying, Sieve Test, Bulk Density etc.

· Knowledge of monitoring/progress of reaction using

chromatographic techniques (checking HPTLC, TLC, UV)

· Preparation of mobile phase and solutions.

· Extraction from plant and analyzing samples. Hands-on experience in extracting Ashwagandha. Fenugreek, Green Coffee, Guarana, Garcinia, Boswellia.

· Wet Lab Analysis of Herbal Extracts for measuring its pH, Total dissolved solids, Loss on Drying, Sieve Test, and Bulk Density.

· Analysis along with online documentation as per GLP requirements.

· Handled SANplus continuous flow analyzer Skalar system with Flow Access V3 software.

· Carry out troubleshooting in the Skalar instrument.

· Handled Agilent HPLC Systems with Empower software.

· Performing analysis of samples through UV Spectrophotometer.