Lakshmi

acguy9@r.postjobfree.com, 972-***-****

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.

.

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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