Medical Device Project
Resume:
SAI VIKRAM
Summary
. Over * years of diversified experience in Validation Methodologies,
Technical Writing and Quality Assurance in Pharmaceutical Industry
with a strong background in performing Computer System Validation and
Software Development
. In depth knowledge of FDA regulations 21 CFR Part 11 and 21 CFR Part
820
. Good knowledge in GAMP4 and GAMP5 practices.
. Experience in validation of Quality systems like Application Server,
Disaster Recovery system, Back Up Server, Supplier Audit Database and
Controlled Spread sheet.
. Excellent experience in validating wide variety of applications and
infrastructure - Business Intelligence Reports, Argus Safety, SAP,
Excel spreadsheets, Electronic Document Management System
(Documentum), LIMS, and AERS
. Experience in configuring, testing, administering and providing
overall system implementation setup of Trackwise, IRMS and Siebel CRMS
. Experience with entire life cycle of Computer Systems Validation
including User Requirements Specifications (URS), Functional
Requirements Specifications (FRS) Vendor Assessment (VA) and System
Design Specifications (SDS).
. Experience in developing protocols, Executing tests and Constructing
Summary Reports for IQ, OQ and PQ for validations in various
pharmaceutical companies
. Good experience in performing manual testing methods like Integration
Testing, Black box Testing, Functional Testing, Regression Testing,
Front end Testing
. Good experience in using automation tools like QTP, WinRunner, Load
Runner & Rational Suite and in designing and development of queries
using SQL, PL/SQL.
. Expert in using Quality Center for managing tests and defects.
. Experience in Validation Procedures, technical writing for systems in
compliance with cGMP, GAMP, cGLP, and cGCPs.
. Experience in writing and reviewing Computer System Validation
Plan/Remediation.
. Extensive experience in writing and reviewing Standard Operating
Procedures (SOPs), Work Instructions (WIs), Requirement Traceability
Matrix (RTM) and Validation Summary Report (VSR).
. Experience in writing Risk Analysis, Gap Analysis, and CAPA documents
. Developed comprehensive Test Summary Report and Test Cases
. Extensive Experience in working with MS Visio, PowerPoint, Word and
Excel.
. Excellent Coordination skills, Communication Skills and strong
Technical Writing skills and a good team player.
. Strong analytical presentation with quick assessment & problem solving
approach.
TECHNICAL EXPERIENCE:
Validation: LIMS (IQ/OQ/PQ) Protocols, FDA Regulations, 21 CFR part 11, GAP
Analysis, GxP (cGMP, GCP, GLP, GDP) Environments, VMP, RTM, SOP, Audit
Trails.
Operating System: WIN NT/2000/XP/7, Mac OS 9, Mac OS X, Linux
Tools: MS Visio, MS Project, MS Office, Documentum, Mercury Win
Runner/ Load Runner,
TrackWise, Argus safety, IRMS, Siebel CRMS
Databases: PL/SQL, MS SQL, MS Excel, Oracle
Bug Tracking and Reporting: Mercury Test Director, HP Quality Center
WORK EXPERIENCE
Ikaria Inc., Madison, WI
Aug 2012 - Present
Validation Lead
Project Name: Medical Device Validation, TrackWise Admin
Responsibilities:
Leaded a team of 14 members for end to end validation on 51 different tools
used in Medical Device development on time and within the allotted budget.
Validated tools including Document Management Systems, Signal Processing
Tools, Circuit Design Tools, Code Compiling Tools, Defect Tracking tools
used in Medical Device Development
Validated the tools based on Windows 7 and Linux Operating systems (Ubuntu
and Debian Lenny).
Performed Risk Assessment for different tools following GAMP5 procedures
Documented the User Requirement Specifications and Design Specifications
for all the tools used in development of Medical Devices
Trained the team regarding the intended use of the tool
Responsible for writing the Validation Plan
Made sure that the team adheres to the guidelines mentioned in the SOP and
training manuals.
Coordinated the team members and held daily meetings for effective
communication of status of the project
Involved in creating System operational and Administration SOP's.
Analyzed Test Scripts to check if it has covered all the functionalities.
Responsible for reviewing and executing IQ/OQ/PQ test scripts.
Responsible for writing the Validation Report that also includes
Traceability Matrix, Anomalies and Remediation Plan
Reviewed all the Validation Deliverables as per SOP Guidelines and in
accordance with Good Documentation Practices (GDP)
Performed configuration of workflows for a project by defining the
activities and also tested the configured project
Documented the Data Migration Plan and Retirement Plan
Performed the configuration of TrackWise coordinator for storing the
records
Used TrackWise integration manager to import and export data
Performed data migration using TrackWise configuration migrator
Determined the migration paths
Prepared and validated migration snapshots for database backup and
restoration and also performed configuration changes with snapshots in
place
Upgraded the migration paths.
Used HP Quality Center for bug tracking, reporting and following up with
development team
Updated the Requirement Traceability Matrix (RTM) upon completion of
Functional Verification and User Acceptance Test execution
Interacted with Subject Matter Experts (SME) to understand and document the
workflow and functionalities on different modules used in TrackWise system.
Involved in performing the GAP Analysis, Root Cause Analysis of the system
and develop Remediation Plan
Responsible for documentation of all aspects of the Computer System
Validation Life Cycle deliverables in accordance with 21CFR Part11
regulations.
As a Member of Change Control Board, made sure all the changes to an
existing system are properly documented and given appropriate change
control numbers
Terumo Medical Corporation, Ann Arbor, MI
Sep 2011 - Jul 2012
Sr. Validation Consultant
Project Name: EDMS, DOCUMENTUM, TrackWise 7.0, IRMS
Responsibilities:
. Responsible for developing Validation Plan
. Designed architectural diagrams, process map/workflow and entity
relation maps of the documents or process using MS Visio
. Written User Requirements specifications, Functional Requirements
specifications document, Design Specification document in compliance
with 21 CFR PART 11 Requirements.
. Reviewed and updated end to end validation documentation for IRMS,
Track wise (CAPA) to ensure compliance with company policies and
procedures.
. Hands on review of the following deliverables - Regulatory
Assessments, Risk Assessments, Validation Master Plans,
Qualification Protocols, Design Reviews, User/Functional
Specifications, IQ/OQ/PQ, Validation Summary Reports, Final
Reports, Gap Analysis/Remediation Plans, User Manuals and Training
Materials.
. Developed OQ and PQ test cases for Track wise and IRMS
. Drafted IQ test cases for verifying configuration of Track wise
workflows.
. Reviewed and tested IBM Cognos reporting functionality for IRMS6.0.
. Communicated and worked with PV group and developed suitable
requirements as per URS specifications.
. Developed Performance Qualification for Citrix based tool MIRS -
IRMS
. Coordinated the execution of Operational Qualifications Test
Scripts with different modules and specifications.
. Assisted in documentation and development of SOPs for Track wise
and IRMS 6.0 application.
. Conducted Regression testing and run the scripts in validated
environment for performance of the application.
. Wrote IQ, OQ and PQ and developed Data migration protocols and
conducted the dry run in Quality Center.
. Developed Detailed Risk Assessment documentation for managing the
risk levels used before validating the system.
. Developed Trace Matrix document for mapping the URS, FS, DS (Design
Specification), IQ, OQ and PQ
. Developed test scenarios for testing workflow paths in Track wise.
. Proficient with Corrective Action Preventive Action (CAPA) workflow
including Investigation, Investigation Task, Action, Request,
Request Extension and Closure phases.
. Performed front end testing, positive and negative testing, GUI
testing, and regression testing
. Performed GAP Analysis and prepared Remediation Plans.
. Conducted reporting and tracking of defects using Quality Center.
. Utilized Documentum and created documentation in all phases of the
SDLC
. Created and maintained the Requirement Traceability Matrix (RTM)
for the application.
. Responsible for storing and maintaining the documents to comply
with 21 CFR Part 11 requirements.
Vitae Pharmaceuticals, Fort Washington, PA
Sep 2010 - Aug 2011
Validation Specialist
Project name: Change Control Management, TrackWise (CAPA), Siebel CRM
Responsibilities:
. Used TrackWise to generate the change control number and manage the
change control flow
. Responsible for analyzing and reviewing validation deliverables like
Validation Plan, User Requirement specification, Functional requirement
Specification, System Design Specification documents of Siebel CRM
. Worked on change control documentation such as Change Request Form
(CRF's), Change Control Implementation Plan, Change Control Summary
Report.
. Developed Validation plan (VP) to define validation strategies
for Siebel CRM including Infrastructure Qualification and
deployment.
. Involved in validating the TrackWise CAPA (Corrective Action
Preventive Action) Business Workflow
. Validated the Integration of the CAPA Workflow with the other
business workflows and the interfaces for the TrackWise
workflow.
. Developed Traceability Matrix to track the requirements during
the QA Testing Phase.
. Executed test cases to verify TrackWise functions, Workflow,
Queries, Scope, End-End flow Approvals, permissions and Reports
. Developed IQ/OQ/PQ test plans, traceability matrices, deviation
forms and validation summary reports (VSR).
. Developed and executed IQ/OQ/PQ test plans and test scripts.
. Reviewed the edited URS/FRS/DS documents as per the change
request.
. Involved in periodic auditing of the change management systems
to ensure that the change management systems are in compliance
with SOP.
. Executed Black Box, Negative, Regression, and Integration &
Security Tests as per the test plans and test scenarios
. Involved in Validation activities for releases within Siebel
CRM.
. Reviewed and edited the URS/FRS/DS documents of Siebel CRM.
. Involved in Data Migration End-to-End testing including
executing the test procedure and writing the Test Analysis
Report for Data Migration End-to-End System Test.
. Involved in the Change Advisory Board (CAB) meetings to discuss
the GxP/PDMA impact of new change requests and the compliance
risk level associated with the change.
. Involved in the discussions with business and IT managers on the
status of open change controls.
. Reviewed and approved the test execution scripts in Quality
Center.
. Managed the testing process in Quality Center
. Ensured that application is in compliance with 21 CFR Part 11
and cGxP regulations.
. Ensured that all the change controls are in compliance with
GxP/PDMA regulations before they are closed out.
. Responsible for writing test plans, test scripts and executing them for
validation testing.
. Reviewed and verified test results, identified and reported issues and
provided summary test reports.
. Expert level knowledge in reviewing and modifying standard operating
procedures (SOP).
Matrix Laboratories, Hyderabad, India
Dec 2008-Aug 2010
Validation Engineer
Project name: Adverse Event Reporting System (AERS) / Argus safety 6.0
Responsibilities:
. Involved in gathering the User Requirements from the System Owners
document for all the software components.
. Validated and developed Argus safety software so that it was compliant
with ICH guidelines and also managed reported adverse events.
. Performed Global adverse effect case data management and regulatory
reporting to the industry using Argus safety
. Developed FRS (Functional Requirements Specification) and DS (Design
Specification) from the URS (User Requirement Specification)
. Responsible for reviewing and documenting Validation Plan, OQ/PQ
protocols and Validation Summary Report.
. Actively involved with the application developers in developing the
high level System Design Specifications (SDS) documents.
. Used MS Visio for pictorial representation of the Design
Specifications and workflow of the process.
. Involved in documenting Vendor Assessment Report from a list of AERS
suppliers.
. Developed Requirements Traceability Matrix (RTM) to track requirements
during the QA Testing Phase.
. Checked the modules of the application and used SQL queries to extract
the data from database.
. Involved with the development team to verify bug fixing and update bug
report status using HP Quality Center.
. Responsible for writing change control SOP's to comply with 21 CFR
Part 11 requirements.
. Developed test plans, test strategies, test scripts for validation
testing
. Validated and developed Argus safety software so that it was compliant
with ICH guidelines and also managed reported adverse events.
. Responsible for developing test protocols for audit trail, time stamp
and electronic signature for the work flow of documents
. Prepared training documentation for the various SOP training.
. Involved in writing audit plans for the quality department
. Expertise in audits and assessments on documents and systems.
Hetero Drugs, Hyderabad, India
Jul 2005- Nov 2008
Technical Writer/ Validation Analyst
Project name: SAP implementation / AERS
Responsibilities:
. Using backward/forward tracing of requirements and finding source
using Requirement Traceability Matrix (RTM) for the application.
. Wrote documents for reports that can be queried by type of adverse
event, disease and principle investigator.
. Created the strategy document that defines the SAP test environment,
phases of testing, entrance and exit criteria into different phases of
testing and resources required conducting the effort.
. Wrote SOPs for training manual, storage and maintenance to comply with
21 CFR Part 11 and GLP requirements.
. Involved in executing the test scripts of SD, MM, PP, WM, IM modules
of the SAP implementation.
. Followed good test practices to document the test evidence (Screen
Prints), Deviations, Resolutions, and Corrective Actions.
. Executed and reviewed the test scripts for new SAP transactions,
Customized transactions, tables.
. Developed Test plan and written several test scripts for validation
testing.
. Wrote GAP Analysis report and Remediation Plan document.
. Reviewed and Documented IQ/OQ/PQ protocols.
. Performed Load Testing, Black Box Testing, GUI Testing and
Functionality Testing for the entire application.
. Developed Test Cases and Test Scripts to perform regression testing
using Win Runner.
EDUCATION
Bachelor of Pharmacy, Osmania University, India.
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