• 7+ years of experience as a Validation/Quality/Compliance Analyst/ Technical Writer in
Pharmaceutical, Biotech and Medical Device industries.
• Strong expertise in FDA regulations, GxP suites (GAMP4 & GAMP5, GDP),
Computer System (CSV) & Equipment Validation, Documentum, LIMS, FAERS,
• Sound knowledge of 21 CFR (Part 11, 50, 56, 58, 210, 211, 312, 314, 820).
• Expertise in writing, reviewing and modifying Validation Master Plan (VMP), IQs,
OQs, PQs, Validation Summary Reports (VSR) and Standard Operating Procedures
• Good understanding of Validation Life Cycle (VLC) and Software Development Life
• Experience with Laboratory Information Management System (LIMS) and integration
with equipment (HPLC, GC, FTIR, Spectrophotometer, pH/EC meter).
• Experience in performing Gap Analysis for FDA compliance and developing
• Working knowledge in validating Adverse Event Reporting System (AERS).
• Excellent knowledge and good working experience on preparing the Risk Assessment
• Involved in Cleaning Validation activities including Recovery Sampling techniques:
Swabs, rinse, rodac, etc. and cleaning protocols generation, execution and reporting.
• Experience with analytical software like Argus safety modules, Trackwise,
• Proficient in Automated and Manual Testing using Mercury Quick Test Professional and
• Expertise in writing Validation Plan, Business/User Requirement Specifications
(BRS/URS), Design Specifications (DS), Functional Requirement Specifications
(FRS), Validation Summary Reports and Traceability Matrix.
• Expertise knowledge in documenting and execution of Test Scripts (IQ/OQ/PQ),
developing Deviation Forms and initiating Change Controls.
• Expertise in calibrating and validating laboratory instruments like Plate Readers,
Autoclave, TOC analyzers, Spectrophotometers, Chromatography (Cation and
Anion Exchange, LC, GC), Fermenter, and Reactors.
• Experience in testing tool using Quality Center.
• Adept knowledge about analytical laboratory procedures, experience in operating
troubleshooting and supporting analytical equipment like HPLC, GC, UV-VIS
Spectrometers, Spectrophotometer, Autoclaves, pH meters and incubators..
• Expertise in database testing with SQL to verify data integrity.
• Experience using 21 CFR Part 11 on keeping Electronic Records, handling Electronic
Signatures and performing Audit Trails.
• Profound knowledge of Crystal Reports Product.
• Capture, analysis, design and development in large application development projects.
• Ability to communicate effectively, enthusiastic, self-motivated, and highly organized.
Validation 21 CFR Part11, cGxP (cGMP, cGDP, cGLP), GAMP, IQ, OQ,
PQ, RTM, SOP, Summary Reports, Audit Trails
Testing and Tracking Win Runner, Load Runner, Quick Test Pro, Quality Center,
Tools Trackwise, LIMS
Languages .NET, C, C++, HTML, SQL,TSL
Operating System Windows OS, UNIX, MAC-OSX
Databases Oracle, Microsoft Access
Analytical Software and Mikrowin, LIMS, AERS, TrackWise
Scientific Software MATLAB
Other Tools MS Office, MS Visio, MS Project
Siemens Healthcare, DE
Jun 2014 – Present
• Worked with all aspects of Computer systems Validation lifecycle, to comply with FDA
regulations 21 CFR part 11, 820, 210, 211.
• Developed Validation master plan and protocols for Installation Qualification (IQs),
Operation Qualification (OQs), and Performance Qualification (PQs).
• Responsible for performing GAP analysis and remediation plans.
• Involved in validating the integrating between CTMS and Interactive Voice Response
System. Performed integration testing to ensure data consistency.
• Investigating the deviations and recommending the required changes.
• Writing SOPs based on cGMP, cGLP for the standardization of the best practices.
• Conducted Automated and manual testing using Quick test professional and Quality
• Maintained Requirements Traceability Matrix (RTM) to continuously track the
• Used SAS to analyze the data and making appropriate changes to the process.
• Wrote SQL scripts to retrieve data from databases.
• Documenting all procedures in accordance to FDA rules and regulations.
• Ensuring all deviations found in operating procedures was resolved before finishing the
Pfizer Inc, CT
Jun 2013 – May 2014
• Helped in scoping the project’s objectives and stakeholder analysis through context diagram.
• As a project team member, participated in every phase of requirement gathering, documents
preparation, supported development team and testing team in order to deliver quality product.
• Performed quality checks on requirement documents (BRS, URS and FRS) and different
supporting artifacts to ensure the quality and consistency.
• Prepared Process Flow Diagrams, Data Flow Diagram, Mockups and other supporting
artifacts in order to surface out all points.
• Analyzed business requirements and segregate them into high level and low level Use Cases
using MS Visio.
• Identified Use Cases from the requirement and wrote Use Case Specifications, created
business process workflow use case diagrams (Activity, Sequence).
• Established effective communication with testing team to ensure proper testing of the
functionalities and participated in quality improvement initiatives and actively apply software
QA methodology standards.
• Participated in revision of design documents to ensure system capabilities as per requirement
• Take initiative to prepare Data dictionary and Conceptual Data Model for project.
• Performed UAT: Identified critical scenarios, prepared Test Plan, wrote UAT Test Cases, Test
Summary Report and coordinated through out user acceptance testing activity
• Make presentations to the end client during UAT.
• Conducted result analysis and interacted with developers to resolve bugs.
• Participated in risk based computer system validation activity.
• Performed Smoke testing on developed application.
• Supported other work stream of the project for the same.
• Performed impact analysis and GAP analysis in order to align business practices and initiated
change control process, through Change management process, as needed.
Biota Pharmaceuticals, GA
Jan 2011 – May 2013
• Designed and developed validation documents for research laboratory including
hardware and software Installation Qualifications (IQ), Operational Qualifications
(OQ), work instructions, best practice guidelines, and other methodology documents.
• Coordinated with System Analyst, Project Manager, and Business Analyst to setup the
pre-validation and Validation environment to execute the scripts.
• Developed Requirements Traceability Matrix (RTM) to track requirements during the
QA Testing Phase. Documented Test Plans, Test Scripts and Test Cases for the User
• Analysed Test Scripts to be complaint with 21 CFR Part 11 which included Audit Trail
Functionality, Data integrity, Data Security and Electronic Signature Functionality.
• Executed test script to test for functionality and regression testing using Win Runner
7.0 I automated load tests using Load Runner 7.5 for testing response time across
network application server and database server and tracked and reported bugs using Test
• Worked particularly on LIMS, handling data for lab and also processing, tracking, storing
and reporting various analytical data and records. I worked both on static data and
• Prepared specification documents for Labstation module of LIMS and created test
scripts for positive, negative, regression and the validation of Labstation module for
interfacing lab instruments with LIMS Lab Ware.
• Performed Computer System Validation Risk Assessment to meet the required
regulatory specifications. I was responsible for development of Remediation Plans for
components that were not full and mostly compliant.
Vertex Pharmaceuticals, MA
July 2009 – Dec 2011
• Reviewed Vendor Audit and Vendor Compliance report for LIMS software
• Worked with project managers and assisted with the implementation of the LIMS
software in compliance with the FDA 21 CFR Part 11 requirements, using GAMP
• Gathered, reviewed, and analyzed the User Requirements and Functional
Requirements and prepared Validation Master Plan (technical writing)
• Participated in meetings with users and Business Analysts to assure better performance of
validation life cycle
• Prepared Technical Design Specification (TDS) document in graphical editor (Microsoft
• Authored installation qualification (IQ), operational qualification (OQ), and performance
qualification (PQ) documents for LIMS
• Developed and executed Test Plans and Test Scripts based on user requirements to
verify complete functionality
• Participated in performing and communicating Risk Assessment pertaining to LIMS
validation, to the quality team and higher management
• Involved in conducting GAP analysis, preparing and reviewing Corrective and
Preventive Action (CAPA)
• Performed manual as well as automated testing to verify functionality
• Performed database testing using SQL queries
• Conducted Data Driven Testing using Mercury QTP and reported test execution using
Mercury Quality Center
• Logged and tracked compliance issues and project related problems and incidents using
• Followed up with the development team to verify bug fixes and updated bug status.
• Participated in the preparation of Requirements Traceability Matrix (RTM) to track
• Prepared Validation Summary Report (VSR)
• Participated in the preparation of Standard Operation Procedures (SOPs)
Med Immune, MD
Jul 2007 – June 2009
• Experience on Design Verification, Design Validation and Process Validation
including mold validation projects for new products, changes in design of legacy
products, and molding process changes to meet increased business demand or improve
customer satisfaction by reducing complaints
• Successfully completed multiple projects for code extension, line extension and
packaging change in the sustaining engineering department with cross-functional & cross
• Provided technical guidance to project teams, suppliers and other disciplines to ensure
global regulatory compliance to international standards, regulations and compliances with
• Proposed & implemented extensive documentation for validation life cycle, which
included validation protocols, IQs, OQs & PQs
• Responsible for laboratory additions, relocations or modifications, Validation Master
Plan revisions, Commissioning Plan development/revisions, various system specific
Commissioning Package development/execution, and facility system drawings review
• Developed risk analysis (FMEA and EURA) for the evaluation of new products and
changes to legacy products/processes to increase focus on critical control points for
design verification and process validation sampling and testing.
• Reviewed non-conformances & recommended CAPAs to address non-conformities &
• Conducted FMEA sessions for Medical Device manufacturers during product
development phases as well as during CAPA remediation as a part of the root cause
• Worked with engineering groups to ensure testing as required on product investigations
• Developed validation procedure for clean room certification to be in compliance with
• Implemented studies and bench-scale experiments to validate new methods and
procedures conforming to current Good Manufacturing Procedures (cGMP)
• Developed SOPs & cleaning validation procedures for process & laboratory
equipment, electro-optic & online process control instrumentation (measurement
systems) & CNC equipment
• Bachelors of Pharmacy
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