PROFESSIONAL SUMMARY

• Extensive experience as Validation Engineer/Technical writer in the pharmaceutical industry with comprehensive understanding of systems testing and technical documentation.
• Validation Planning, Execution and Closure.
• Requirements Gathering, Documentation (User Requirement Specifications (URS), Functional Requirement Specifications (FRS) ).
• Software Development Life Cycle (SDLC) and Software Validation Life Cycle (SVLC) in Waterfall / Agile Environment.
• Developing Validation Master Plan (VMP), Test Plan, Test Cases, Validation protocols like Installation, Operational, Performance Qualification (IQ/OQ/PQ).
• Designing Requirement Traceability Matrix (RTM), Gap Analysis, Remediation plan, Validation Summary Report (VSR), Test Summary Report (TSR).
• Unit Testing, Integration Testing, System Testing, Regression Testing, Load Testing, Migration Testing, User Acceptance Testing (UAT), White Box and Black Box Testing and Manual Testing.
• Writing Standard Operating Procedures (SOPs), User Manuals.
• Good Documentation Practice (GDP).
• Writing SQL queries for backend testing and maintaining databases.
• Issue/Bug Tracking/Reporting using Dashboard, Quality Center (QC), Quick Test Professional (QTP), JIRA, LoadRunner.
• Good experience in performing Procedural Remediation - system procedurally.
• Experience in technical writing and good management skills.
• Experience in providing guidance on validation documentation.
• Good Team Player and have the ability to work independently.

PROFESSIONAL EXPERIENCE

Confidential, Lexington, MA

Validation Specialist

Responsibilities:

• Write, edit and review scientific and technical documents (Standard Operating Procedures, Product Specifications) and assist project teams in collecting and organizing information.
• Prepare, maintain, or review Test Method documents to record changes in methods.
• Complete documents and other assigned tasks within established timelines and with high quality in terms of scientific content, clarity, accuracy, format, consistency and adherence to regulatory and internal guidelines, style and processes.
• Utilize Master Control system to schedule review of documentation and drive effectiveness within target timelines.
• Access Change Control activities on TrackWise system to make necessary changes to the document and work towards getting the document effective.
• Time management of documents going through Change Control process to meet the required deadlines.
• Submit Service now tickets and follow up regularly to get the LIMS build updated for each revision.
• Close incident reports after the document goes effective.
• Maintain standardized language and documentation practices that allow consistent execution of defined activities.
• Complete data entry in Laboratory Information Management system (LIMS) and run reports.
• Generate Certificate of Analysis (CofA) in LIMS to summarize all the testing performed on the referenced product or material demonstrating its acceptance against certain specifications.
• Communicate key milestones and deliverables including follow up and active communication on issues and potential roadblocks.
• Create Performance metric to record productivity results of all the labs by every month-end.
• Work with Training coordinators to ensure that training requirements are up to date.
• Involvement in other QC activities such as Records Retention, if required
• Documented business requirements and provided quality control oversight in designing Validation Master Plan (VMP).
• Developed Standard Operating Procedures (SOP’s) in compliance with CFR Part 210, 211 Part 11.
• Involved in preparing technical documents like user requirement specifications and functional requirement specifications etc.
• Prepared test cases and test scripts testing functionality for lot and batch management.
• Worked on writing and testing IQ, OQ and PQs for the implementation of updates.
• Developed Requirement Traceability Matrix (RTM) to track test cases against the requirements.
• Prepared Validation Summary Report (VSR).
• Involved in performing GAP analysis, preparing Remediation Plans and made incident reports
• Updated Installation guide for the working application.

Confidential, Foster City, CA

Validation Analyst / Technical Writer

Responsibilities:

• Collaborated as SME on the Documentum 5.3-based document repository, defining folder structures, permission ACLs and version control
• Developed, implemented and ensured compliance with document standards consistent with the SDLC followed in Gilead (Gilead’s current ELC standards)
• Performed Validation of Documentum 5.3-based document repository used to store regulatory data
• Performed Gap Analysis and reported current state of the systems’ adherence to 21CFR Part 11 compliance
• Performed risk-based Retrospective Qualification of the custom migration tool used to transfer documents over to the DMF environment
• Involved in Gilead Internal Audit of the DMF environment
• Authored and reviewed technical documentation like Project/Engineering Plan, User and Functional Requirements Specification (URS/FRS), Traceability Matrix, Validation/Test Plan, IQs, OQs, Validation/Test Summary Report
• Developed Test Scripts/OQs for performing Positive, Negative and Regression testing as part of the validation effort
• Developed best practices for managing IQs, in terms of developing and managing an IQ Pool Index to ensure unique identifiers for each IQ and its version control
• Developed and maintained SOPs and User Guides for processes and use of digital signatures adhering to GxP standards
• Managed the document review/approval cycle and document tracking tools to ensure timely approval of documents utilizing the Digital Signature tool in the role of a Document Administrator for all project deliverables
• Created the Master Support Plan outlining a standard support process and escalation route for any DMF project
• Developed the Ticket Handling Process from logging the issue in Peregrine Service Center 6.0 through its resolution and close out, involving Level 1, Level 2, Level 3, Technical Team, and Vendor as sources of support
• Authored Support Deliverables like Process-Flow Diagrams in Visio and Checklists aiding efficient support delivery
• Managed all program and work-stream documentation in SharePoint Server 7.0 as well as Documentum 5.3-based document repository
• Managed project issues and actions from their inception through close out in SharePoint server 7.0
• Supported the Project Manager at ELC checkpoints by ensuring that all documentation prerequisites were met and electronic copies were posted to the document repository within the specified timeframe
• Developed, maintained and managed the FAQs and Project Glossary
• Participated in various Training programs mandated by the Program like GxP Standards, Gilead’s ELC methodology, Computer System Validation, IQ Execution, Acceptable Use of Gilead Systems, Gilead’s Policy for Handling Personal Information, and HSI (Handling Sensitive Information) Guidelines

Confidential, Longmont, CO

Validation Analyst / Technical Writer

Responsibilities:

• Create strategies for following timelines for remediation process involved
• Met with team members to follow up on the Part 11 System Assessment reports for identify the findings
• Discuss the findings with Subject Matter Experts, in order to achieve resolution on the SOP updates
• Revise Standard Operating Procedures based on the remediation strategies, and changes in procedural control, conforming to 21 CFR Part 11
• Maintain SOP updates, and progress for various systems
• Route documents for completion of their approval through Electronic Document Management System
• Attend Project meetings to discuss and update the testing activities and validation deliverables.
• Coordinate with the Quality Control department to ensure operational qualification (OQ) activities were executed successfully in the validation environment.
• Identify and documented variances in exceptional conditions information log for installation and operational qualification test scripts.
• Facilitate work for document completion from document drafting to final approval and updates
• Work with other team members to complete the project in the pre decided timeline
• Worked with teams from Information Systems, Operations and Quality, and Facilities and Engineering to coordinate the project
• Generate project schedules of decommissioning activities for the systems
• Met with Subject Matter Experts to discuss the strategies to carry out the decommission process
• Facilitate the execution of various activities leading up to the decommissioning
• Create documents in Electronic Document Management System, and managing the document lifecycle in the system
• Work on the Part 11 System Assessment, as a part of the Periodic Review of the system
• Facilitate a part of the Periodic Review, which includes system users assessment
• Create various System Manuals which would be used as a reference document for FDA Inspections
• Facilitate various documents in the Electronic Document Management System, to complete their approval

Confidential, East Hanover, NJ

Technical Writer

Responsibilities:

• Worked closely with users, and the enterprise application group to understand and document user requirements, and functional design specifications.
• Followed Novartis’s SLC during creation of the documents related to testing.
• Created Requirement Traceability Matrices (RTM) from the Functional Requirements and other specifications documents.
• Generated change controls forms for updates to system functionality to validated applications.
• Authored Test Summary Reports (TSR) at the end of each testing cycle and Validation Summary Reports (VSR) at the end of the validation process.
• Developed Validation Master Plan (VMP) that outlined the testing activities.
• Prepared all required documents in validation lifecycle in agreement with FDA regulation including Validation Master Plan (VMP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for SQL*LIMS.
• Developed and executed validation guidelines for testing cGxP sensitive transactions.
• Worked both independently and cooperatively with other team members on multiple projects with competing deadlines.
• Designed test plans and test cases for testing the functionalities of the applications.
• Performed positive, negative, unit, integrated and system testing to existing applications.

Confidential, Groton, CT

Validation Analyst / Compliance Analyst

Responsibilities:

• Drafted and reviewed Requirements Specifications document and add new requirements in consultation with the system users, business strategy and vendor capabilities.
• Processed Validation Protocols such as IQ’s, OQ’s and PQ’s that are parts of the Validation Master Plan.
• Analyzed the Validation test scripts and documented the functional requirements and results as per the FDA regulations.
• Responsible for validation deliverables on ARGUS 2.9.1g upgrade.
• Analyzed the SOP’s that were documented for each system and briefly worked on ERP system.
• Used SAP and validated CRM module for compliance.
• Performed Manual and Automated Testing Using Quick test professional for Front-End functionalities and Back-End operations
• Ensured that the system is in compliance with the 21 CFR part 11 electronic records and electronics signatures regulatory standards which included automatic date-time entry, multi-level password security and secure system sign-on features.
• Maintained the Requirements Traceability Matrix (RTM) and frequently updated it to map the test cases to new requirements.
• Worked in parallel with SA, QC and ISS departments.
• Validated analytical laboratory equipments such as GC, HPLC, Autoclaves and Incubators in compliance with FDA regulations.
• Involved in validating computer system interface with laboratory equipments such as Spectrophotometer, HPLC, GC and Autoclave
• Customized and validated different components of the LIMS modules
• Acquired and documented the business requirements
• Prepared Validation Master Plan (VMP) for validating analytical laboratory equipments and LIMS.
• Hands on experience in formulating Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) for validating
• Executed IQs, OQs and PQs to check the functionality of the system
• Generated Validation Summary Report to summarize and document all validation activities
• Developed and reviewed Standard Operating Procedures (SOPs) for various functionalities of the system.
• Validated and tested Empower Chromatography Data Software by Waters.
• Analyzed test scripts to check whether all functionalities have been covered within the compliance of 21 CFR Part 11.
• Developed test scripts and test cases for automated and regression testing using Quick Test Professional (QTP).
• Handled multiple projects and change requests simultaneously without compromising project
• Assisted in developing a Remediation Plan for various compliance issues like Change Control.