Experience

Nostrum Laboratories, Inc.

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Validation Manager (Technical Services)

  • Mar 2018 - Present

• Supervisor, validation (Technical Services)

  • Apr 2014 - Feb 2018

• Validation Associate

  • Feb 2012 - Mar 2014

  - Write and execute Validation and Commissioning protocols.- Collect and analyze data, write final report and obtain approvals.- Plan, Perform and document commissioning and validation activity (DQ, IQ, OQ and PQ) for equipment, facilities and utilities in manufacturing environment. - Write/Review/update SOPs governing the overall validation program.-Coordinate successful execution of projects by working effectively with different functional groups.- Conduct Process Validation for Products / Cleaning (Manufacturing and Packaging).- Assist in investigations of deviations and non-conformance reporting Assure project documentation is accurate and in compliance with cGMP regulations. Show less



Stevens Institute of Technology

• United States
• Higher Education
• 700 & Above Employee

• Research Associate

  • Jan 2011 - Jan 2012

  - Six Sigma Cleaning Validation Project – Time and Cost reduction on cleaning procedure for Pharma Company - Developed bench-scale cleaning process model - Determined optimal cleaning parameter for hard to clean products - Performed Design of Experiments for the cleaning process of vessel on the model. Data analyzed using Cube Plot, Main Effects Plot, Interaction Plot, Normal Effect Plot and Pareto chart from Minitab 16 - Performed “Visual Inspection Study” to determine the Accuracy, Precision, Linearity and LOD/LOQ of visual inspection using standard coupon for waters – ERA - Performed “2010 Warning Letters Analysis” to determine most common citation targeted by US-FDA - Prepared and maintained Laboratory notebook as per cGMP - Conducted audit of SPRC laboratory as per cGMP - Prepared SOPs, Protocol and Reports for experiments and instruments - Trained Students and maintained in laboratory for general housekeeping and safety procedures - Ensured documentation was as per cGMP and was consistent and correct - Performed gap analysis on SPRC Laboratory for ISO certifications - Implemented Lean-Six Sigma concept to resolve compliance issues - Developed and Validated swab method for 2 detergents, Sodium Lauryl Sulfate and Micro-90 using Sievers TOC analyzer - Developed and Validated swab method for Koch Hi-Voltage degreaser using conductivity meter – Davol Inc. - Developed and validated Excel spreadsheet for preparing standard solution for TOC (KHP) Show less



Virdev Intermediates Pvt. Ltd.

• Virdev Intermediates Pvt. Ltd.

  • May 2007 - Aug 2007

  - Collected, documented and processed QC test data - Developed and reviewed SOPs, Batch record and Protocols - Controlled manufacturing process and maintained logbook as per GMP - Supervised packaging of bulk drug - Collected, documented and processed QC test data - Developed and reviewed SOPs, Batch record and Protocols - Controlled manufacturing process and maintained logbook as per GMP - Supervised packaging of bulk drug