Quality Assurance Project

Pooja Seth

Validation Analyst

*****.*******@*****.***

Summary:

Validation Analyst with over 5 years of experience in Pharmaceutical and Biotechnology industries

focusing on Computer System Validation, Process Validation, Equipment validation, Instrument Validation,

Cleaning Validation and Software Quality Assurance.

Special Expertise:

• Excellent skills and knowledge on tools for Requirement Traceability Matrix and Version

controls systems.

• Experience with 21 CFR Part 11 (Electronic Records, Electronic Signatures, audit Trails and

Security events) 21 CFR Part 210, Part 211, Part 820, ISO 13485, ISO 14971.

• Extensive experience in performing Risk Assessment and developing Validation Master Plan.

• Expertise in developing User Requirement Specifications (URS), Functional Requirement

Specification (FRS), Software Design Specification (SDS), and Hardware Design Specifications

(HDS).

• Expertise in writing Validation Protocols Installation Qualification (IQ), Operational Qualification

(OQ) and Performance Qualification (PQ).

• Experience in writing and developing Test Plans, Test Cases, Test Scripts, Test Criteria, Test

Procedures, and Test Summary Reports.

• Excellent understanding of the Software Development Lifecycle (SDLC) and its Methodologies

like Agile, Waterfall, V model and Spiral.

• Good understanding and practical knowledge of GxPs like GLP, GCP, GMP and GAMP4 &

GAMP5

• Excellent documentation skills in compliance with Good Documentation Practices (GDP).

• Expertise in technical writing and reviewing of Standard Operating Procedures (SOPs), Work

Instructions and User Manuals.

• Expertise in Validation Testing Life Cycle period using the manual and automated testing.

• Expertise in conducting Gap Analysis and developing Remediation Plans. Excellent knowledge

and good working experience on preparing the Corrective Action Prevention Action (CAPA),

Change Control Process, Deviation Reports and Risk Assessment documents.

• Good knowledge of Laboratory Information Management System (LIMS) software and Scientific

Data Management System (SDMS).

• Proficient in using Documentum and Trackwise.

• Experience in handling/validation of HPLC, HVAC, TLC, GC, UV-Vis, Autoclaves, Sterilizers

and Ovens.

• Extensive experience with automated testing tools like Quality center, Quick Test Professional,

Win Runner, Load Runner and Test Director.

• Strong Verbal and Written skills for clearly delegating tasks to team numbers and for effectively

communicating results to management.

• Excellent Interpersonal, analytical and organizational skills with quick learning ability.

Page 1 of 5

Project Experience:

Actavis, Elizabeth, NJ January, 2012-Present

Validation Analyst/Business Analyst

Project 1:

The project involved customization and validation of LabWare LIMS as per 21 CFR Part 11 . Guidelines

were prepared for the integration and validation of new laboratory instrumentation in compliance with

cGxP and validation documentation.

Responsibilities:

• Validated the process to comply with the FDA rules and regulations.

• Participated in SDLC planning, implementation and documentation.

• Developed SOPs for Validation Plan, Test Cases and Test Procedure.

• Reviewed validation deliverables such as VMP, Validation Protocols, and VSR.

• Helped qualify the terminals and machines for optimal configuration using IQ and OQ.

• Involved throughout the testing and documentation phase of the Computer System Validation

project.

• Managed system upgrades, enhancements, and maintenance in a cGMP environment

• Documented Test Scripts to check for compliance with 21 CFR Part 11 rules of the FDA.

• Performed GAP Analysis and developed the corresponding Remediation plan.

• Conducted UAT to make sure that all the user requirements are met and maintained

communication with team members, stake holders.

• Validated the Electronic Records and Electronic Signatures in accordance with the FDA

guidelines.

Project 2:

TrackWise for Quality Assurance

TrackWise provides a mechanism to automate and enforce quality workflow processes in a centralized

database and supplies a validated, secure, regulatory compliant, technical infrastructure to define, track,

manage and report on core Quality Assurance activities. The purpose of this project was to add and

configure non-medical workflows such as Complaint, Investigation and Exceptions.

Responsibilities:

• Conducted requirement analysis and design walkthroughs sessions with the Business System

Owners, Developers, Business Users and Management staff.

• Prepared a comprehensive set of documents to define the requirements and functional

specifications

• Participated in Validation plans per the business requirements document.

• Created and executed Test Cases

• Facilitated User Acceptance Test (UAT).

• Worked closely with validation team to ensure testing issues were resolved.

• Worked closely with the project Manager in planning, coordination and implementing

methodology.

• Interacted continuously with developers and Validation team to maintain schedules for release,

bug fixes and other issues related to the system

• Facilitated weekly team meetings between business users, developers and tester where test

status and defects were discussed.

Mylan Pharmaceuticals, Morgantown, WV December, 2010- December, 2011

Validation Analyst/Technical Writer

Project 1:

Page 2 of 5

QTS is a management software package (Trackwise) that can be configured into automating quality

process workflows. Its purpose is to automate the collection of applicable data and signature approval

process for the Internal Audit, External Audit, Corrective Action and Preventive Action (CAPA) system

and Global Supplier Quality Tracking System.

Responsibilities:

• Analyzed Raw Material, Finished Good, CAPA, and Audit workflows to understand the business

requirements.

• Conducted requirement analysis and design walkthroughs sessions with the developers, business

users and management staff.

• Prepared Requirement and Functional Specification and Trace Matrix documents.

• Conducted manual testing and Interacted continuously with developers to report issues related to

the system functionality.

• Involved in creating the Qualification protocol.

• Developed and executed IQ and OQ test cases and prepared IQ/OQ and IQ/PQ reports.

• Created incident/investigation reports (IR) to report and resolve issues related to system

functionality.

• Worked closely with Validation Lead and QSR to review the post execution of the IQ and OQ test

cases.

• Worked closely with validation team to ensure testing issues are resolved.

• Involved in User Acceptance Testing.

Project 2:

This project involve in validation of SDMS (Waters NuGenesis) that manages both structured and

unstructured data and facilitates product development, regulatory compliance and laboratory productivity.

Responsibilities:

• Involved in Design, Development and Management of Scientific Data Management

Syste(SDMS) in accordance to the 21 CFR part11.

• Prepared test plans and test cases for the Database system.

• Involved in preparation of Conformance Standard Documents

• Involved in data transfer and validation for EDM and EDC systems.

• Used Test Director for presenting reports and bug tracking.

• Developed Requirement Traceability Matrix (RTM) to track requirement during QA testing

phase

• Involved in preparing compliance reports about existing status of cGMP, GLP and GCP.

• Interacted regularly with Supervisors, Analysts and Quality personnel.

Cubist Pharmaceuticals, Lexington, MA October, 2009-December, 2010

Validation Analyst

Cubist is a biopharmaceutical company focused on the research, development and commercialization of

pharmaceutical products that address unmet medical needs in the acute care environment .The project

involved Compliance tracking as well as Documentum (version 6.0) which includes documentation,

execution and review of plant validation activities and also played a major role in providing leadership

across a number of QA functions.

Responsibilities:

• Developed 21CFR Part 11 Assessment Plan for the application.

• Made deviation investigations, SOP and quality system development.

• Analyzed IQ/OQ/PQ Test Scripts to check if it has covered the functionalities, which need to be in

compliance with 21 CFR Part11 rules set by FDA.

Page 3 of 5

• Participated as a team member to draft a Remediation Plan for Project Management approval

after Gap Analysis.

• Generated the detailed reports of the bugs, pass-fail report and comparison chart.

• Defects were logged, tracked, reviewed and analyzed using Test Director.

• Documented the verified test result after executing the scripts.

• Worked with development team to ensure testing issues were resolved.

• Validated computer systems and laboratory equipments according to FDA regulations.

• Assisted in the maintenance of the CAPA and Quality Metrics program.

• Worked closely with the Compliance and Validation Team Leader in this process.

• Conducted compliance audits and walk-downs and completed all the necessary follow-up reports.

• Conducted GAP analysis to identify compliance of 21 CFR PART 11 and formulated Remediation

Planning and prepared Validation Summary Report (VSR). Involved in gathering user

requirements.

• Complied in strict accordance with FDA and GCP regulations for all aspects of computer system

validation cycle.

• Participated in the assessment for the requirements of 21 CFR Part 11.

• Involved in the preparation of Validation Master Plan.

• Updated requirements and maintained traceability using Requirement Traceability Matrix (RTM)

• Developed standard operating procedures (SOP’s) and trained users on SOP’s

• Prepared Validation Test Summary Reports.

• Carried out GAP analysis and in turn prepared Remediation Plan.

• Proficient in writing manual test cases and test scripts.

• Prepared detailed user friendly compliance reports of the documentation of the installation

qualifications, operating as well as performance qualifications validation protocols in agreement to

FDA standards.

• Extensively used Documentum to store and retrieve documents.

• Actively participated in project meetings and discussions.

• Managed and coordinated the Validation Change Control System (VMP) and all related

documentation along with leading the Validation Review Board.

• Attended seminars conducted by FDA dispersing regulations to be implemented in 21 CFR Part

11.

• Performed GAP analysis to ensure compliance with cGxP.

• Developed Remediation Plan to bring the system in compliance with GxP and prepared Validation

Summary Reports (VSR).

• Maintained Requirement Traceability Matrix (RTM) to keep track of user requirements.

Nova Biomedical (Waltham, MA) June, 2008- August, 2009

Validation Analyst/Technical Writer

Project 1:

The project involved validation of an Electronic Document Management (Documentum – FirstDoc)

system for organizing regulatory, clinical, quality, and nonclinical data using document life cycle

management. Also, validation of a product labeling system required developing labeling documents in

compliance with FDA/regulatory standards for labeling medical devices and drug products.

Project 2:

The project involved validation of a Medical Product Lifecycle Management (Teamcenter) system. It

will manage product data of medical devices. Also, documentation regarding quality processes, policies,

compliance, manuals, validation in a single unified system.

Responsibilities:

Page 4 of 5

• Validated the Electronic Document Management system per the risk assessment and carried out

assessment for the requirements of 21 CFR Part 11

• Developed SOP’s and User Manuals in preparation to support the production system.

• Reviewed URS, FRS and SDS documents to ensure completeness and correctness.

• Performed Gap Analysis by mapping trace matrix to identify existing/potential non-conformity with

health care system regulations and/or incompleteness of validation.

• Authored, reviewed, updated and executed validation protocols (IQ, OQ, PQ) to ensure correct

system validation.

• Developed and executed manual and automated test cases to verify the functionality.

• Prepared Dashboard to keep track of the test activities.

• Reported issues using JIRA and documented incidents reports to rectify them during validation.

• Developed business process improvement strategies.

• Configured Documentum version to ensure compatibility with other equipment’s.

• Maintained the Requirement Traceability Matrix.

Education:

Bachelors in Biotechnology, Mumbai University, India

Masters in Clinical Research Administration

University of Texas, Austin

Page 5 of 5

Contact this candidate