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Click here or scroll down to respond to this candidate Lakshmi
EMAIL AVAILABLE, PHONE NUMBER AVAILABLE
SUMMARY:
Having 2 years of experience in Validation with strong background in Pharmaceutical Industry.
Extensive knowledge of validation of computer systems and manufacturing processes.
Strong understanding of 21 CFR Part 11, Validation Strategies and Documentation, GAMP, GxP s
(GCP, GLP and GMP).
Emphasis on manual and automated testing with thorough understanding and knowledge of
Validation Life Cycle and Software Development Life Cycle (SDLC).
Skilled in developing Standard Operating Procedures (SOPs), policies and working instructions to
comply with FDA regulations.
Comprehensive knowledge and extensive experience in technical writing of Validation protocols
(Computer System Validation (CSV), Design Qualification (DQ), Facility and Utility Qualification,
Installation Qualification IQ, Operational Qualification OQ), Validation Master Plan (VMP),
SOP s, SAT, Test Summary Report, Test Plans, Test scripts, and Requirement Traceability Matrix
(RTM) in FDA regulated environments.
Knowledge in Cleaning Validation, Performance Qualification (PQ), Continuous Quality
Validation(C/Q/V) and Kaye Validator.
Experienced in performing periodic reviews and GAP analysis for identifying compliance gaps,
developing Corrective Action and Preventive Action (CAPA) and implementing them.
Extensive Experience in working with PowerPoint, Word and Excel.
Excellent interpersonal, organizational, verbal and written communication skills.
WORK EXPERIENCE
UCB Pharmaceuticals November 13 Present
Seymour, Indiana
Validation Engineer.
Worked in collaboration with Production, Quality Assurance departments to execute Validation of
Equipments.
Equipments Validated: Bin Blender, Coating Pans, USP Water System, Tablet Metal Detector,
Capsule Filling Machine, Capsule Conveyor, Solution Tank, Miele Washer,
Fluidized Bed Dryer, PLC and HMI software s, Tablet Press.
Responsibilities:
Execution of the Equipment Validation.
Reviewing and Updating of the Protocol and SOP's.
Preparation and execution of Site Acceptance Testing (SAT), Installation Qualification (IQ) and
Operation Qualification (OQ) for various equipments.
Involving in writing the IQ and OQ protocol for USP Water System.
Verifying the Engineering Equipment drawing with the Equipment and Redlining the Engineering
drawings.
Handle the tasks of testing hardware and software components and performing Computer System
Validation (CSV).
Responsible for identifying gaps and recommending solutions to software validation processes,
procedures and practices.
Ensure accuracy and completeness of software validation records like validation Plan, installation
qualifications and operational qualifications.
Involving in assisting in developing a Test method template for future validation
requirements.
Conducting training on good documentation and good testing practices.
Participation in establishing standard quality and validation practices.
Involving in weekly and monthly meetings to discuss the work plans.
Interaction with the Operators, Production and Maintenance departments to ensure
accurate Validation results.
Preparation Deviation reports after execution of protocols.
Preparation of Validation Summary and Validation Final reports.
Analyzing the Validation data and Report results.
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Biological. E. Limited August 2010 - July 2011
Hyderabad, , India
Validation Engineer.
Developed, executed and maintained validation methodology in accordance with applicable regulatory
requirements and industry best practices.
Equipments Validated: Gas Chromatography (GC), High Performance Liquid Chromatography
(HPLC), Mass Spectroscopy (MS), UV-Visible Spectrophotometer, Hoods,
Centrifuge, Incubator, Cabinets, Stability Chambers, Cold Rooms.
Responsibilities:
Created IQ and OQ Protocols Scripts.
Involved in creating Risk Assessment document.
Performed change control by assessing proposed changes to validated processes.
Created Validation Plan, Test Plan Documents as per FDA and company standards.
Implemented Standard Operating Procedure (SOPs) of validation protocols to enhance and control
the quality of the services to ensure compliance with FDA regulations.
Performed quality check to verify the performance quality of the services
Involved in project scheduling and deciding Timelines for activities related to validation.
Prepared Requirement Traceability Matrix (RTM) to track requirements and to co-relate with the
conducted test cases using QC.
Responsible for creating and executing Test Scripts in accordance with Good Testing Practices and
Good Documentation Practices.
Involved in reviewing Corrective Action and Preventive Action (CAPA) and performed GAP
Analysis for processes.
Developed and executed validation guidelines for GMP, GCP and GLP
Attended daily status meetings with Project management on testing updates.
Involved in preparation of Validation Summary Report (VSR).
NATCO Pharmaceuticals June 2009 - August 2009
Hyderabad, India
Internship
Observed the procedure involved in Research and Development department of developing a new
method and formulation at pilot scale by following GLP and GMP.
Gained knowledge in the Production department about the production of beads by following the
SOP and coating of beads and drying them following GMP.
Carried out Dissolution and Disintegration of the tablets manufactured and reviewed the SOP s in
the Quality Control department.
Observed the final packaging procedure of the tablets into containers and bottles followed by
labeling in the Packaging and Labeling department.
EDUCATION and RESEARCH
Masters in Pharmaceutics September 2011 - August 2013
Arnold and Marie Schwartz College of Pharmacy, Long Island University, Brooklyn, NY
Project: Worked on "Linear Drug Release Profiles from Matrix Tablets by Compressing with modified
Methylcellulose A"
Tested the release pattern of the drugs using Different Instruments (DSC ,FTIR and
NMR) with Modified and Unmodified Methyl Cellulose Excipient.
Studied the Physical Characteristics, Dissolution and ADME parameters (Pharmacokinetics) of the
drugs (Acidic, Base and Neutral Drug) with this Excipient and studied the results.
Established the Linear Drug Release Profile Characteristics of the drugs with Modified
Methylcellulose-A.
Research Project: December 2011 - May 2013
Molecular and Biology Lab Long Island University, Brooklyn, NY
Worked on GLP family genes and Tornado-2 gene and studied their Interactions
Completed Gene Transfection and verified with PCR and Western blot.
Studied the Interaction of the Gene with the Yeast cell Interaction
Special Project February 2013 - May 2013
Conducted a research project on Method Validation of Diphenhydramine by High Performance
Liquid Chromatography.
Performed assay of Diphenhydramine and validated it in terms of linearity, accuracy, precision,
lower limit of quantitation, detection of unknown concentration and recovery by following cGMP
and GLP guidelines.
Acquired knowledge of WinNonlin software.
Bachelors of Science in Pharmacy September 2006 - July 2010
Jawaharlal Nehru Technological University, Hyderabad, India
Thesis: "Phytochemical Investigation and Formulation Development of Different Varieties of Linseed"
September 2009 June 2010
Extracted, Separated and Analyzed the Active drug from six different species of Linseed Plant and
species with highest amount of Active drug was selected using GC.
Formulated the Emulsion and Cream dosage forms of the extracts of Linseed.
Evaluated and proved that the Emulsion dosage form was showing the maximum Efficacy and
Bioavailability.
Technical Skills:
SAS Programming , SQL Programming Proficient in MS- Office, Reporting Tools - Cognos 10.1.1
(Report Studio , Framework manager , Transformers).
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