Validation Engineer Technical Writer
Resume:
Shilpa Marampalli
******************@*****.***
PROFESSIONAL SUMMARY:
Validation Engineer with 8+ years of experience in the Life Sciences industry with emphasis on Computers Systems Validation and Quality Assurance of various Computerized Applications and Equipment in compliance with FDA (US) and Health Canada regulations.
Knowledge and experience of FDA compliance of 21 CFR Part 11, 58, 210, 211 and 820 and cGxP (GMP, GCP, GLP, and GAMP, GAMP4 & GAMP5) standards.
Knowledge on Software Development Life Cycle (SDLC), familiar with Waterfall, Agile, Spiral and V-Model.
Expertise in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS).
Expertise in designing Testing documents like Test plan, Test cases and Test procedures.
Knowledge in various types of testing such as Load testing, Stress testing, Performance testing, Positive testing, Negative testing, User Acceptance Testing and Unit/Smoke testing using manual and automated tools
Specialize in developing and implementing appropriate standard operating procedures (SOP) and Standard working Practices (SWP).
Good knowledge and experience working on Analytical Instrument qualification, Analytical method validation, System Suitability Test and QC check samples (USP1058)
Working knowledge in MS project, Adobe Acrobat, MS Office and SharePoint
Great team player with strong analytical, critical thinking and problem-solving mindset coupled with proven leadership, interpersonal and communication skills. Strong ability to excel in challenging environment, requiring minimal supervision.
Experience in performing Gap Analysis and suggesting the Remediation Plans to mitigate the non-compliance.
Expertise in reviewing and performing Corrective and Preventive Actions (CAPA), Deviations and Change controls
Developed Standard Operating Procedures (SOPs) and trained users on SOPs for many analytical instruments and manufacturing methodologies.
Excellent analytical skills combined with quantitative approach to problem solving.
PROFESSIONAL EXPERIENCE:
Johnson & Johnson, Raritan, NJ 10/2019 to Present
Validation Engineer
Perform computer system validations to ensure compliance with 21CFR part 11.
Directly investigate and implement CAPA activities.
Documented URS, IQ, OQ and PQ for Version upgrade. Reviewed URS and FRS documents for Jira application. Documented Validation Plan, Test plan, Functional Specifications, Qualification Protocol and Test cases.
Participated in meetings with IT Project Manager, Validation Analyst to track project status and to verify the project progress complies with the project schedule.
Created Data Migration scripts and monitored the extraction and transfer process.
Gathered requirements, reviewed, and approved Requirements Specification document as part of IT tools validation. Reviewed and approved related documents such as Validation/Compliance Plan, Test plan, Requirements Specification, Functional Specifications, Qualification Protocol, Test cases.
Used Quality Center for managing Requirements, Test Plan and Test Cases. Wrote and Reviewed Test plan, Validation/Compliance plan, Validation/Compliance Summary Report for the validation of IT tools.
Reviewed the SOPs and policies and regulations.
Responsible for handling the objective evidence, managing the associated deviations, and escalating the system issues.
Involved in analyzing possible Issues, Risk assessment and mitigation and maintaining Deviation Records.
Initiating and updating Change Control for updating the Version as per Quality System Impact procedures.
Worked with the Development team, Change Management team, Technology, Business and Compliance approval teams to move the Change Requests to different environments.
Reviewed and enhanced Change Requests created by the Change Control team.
Juno Therapeutics, Seattle, WA 05/2018 to 09/2019
Validation Engineer
Responsible:
Extensively used Documentum for storage and retrieval of documents.
Responsible for the entire Validation Life Cycle and ensured that the application is in compliance with 21 CFR Part 11 specifications.
Responsible for the development of High-Level Risk Assessment for the computerized system concerning regulatory, legal and information security topics.
Developed the Electronic Records and Electronic Signatures Assessment document by performing Part11 assessment to the components Responsible for maintenance of Electronic Records, Electronic Signatures and Audit Trails in accordance with 21CFRPart11 regulations.
Developed the User Requirements Specifications (URS), Functional Specifications (FRS) and the Design Specifications (DS) document.
Created and Reviewed Operation Qualifications (OQ) and User Acceptance Testing (UAT) test cases for different modules of LIMS based on the User and Functional Requirement specifications (UFRS).
Responsible for the validation of Adverse Event Reporting System (ARISg and ARGUS Safety), EDMS, GxP Assessment database, Change Management System, Clinical data management System (CDMS).
Reviewed cross release SDLC deliverables like Requirements Specification, Design Specification, Requirements Traceability Matrix (RTM), test scripts to ensure adherence to SDLC and Merck policies and procedures.
Reviewed Unit and System test scripts using automated testing tool, ALM.
Developed, reviewed and approved the Installation Qualification, Operational Qualification and Performance Qualification test scripts to check if all the functional requirements are meet.
Extensive experience building Test cases, Test procedures and Test reports.
Conducted various types of testing: User Acceptance Testing, Smoke Testing, Black Box Testing, Load and Stress testing using manual and automated testing tool
Tracked, Investigated and resolved Bugs and defects using HP Quality Center, Win Runner.
Prepared Deviation Reports when the test criteria did not meet the acceptance criteria.
Developed Requirements Traceability Matrix (RTM) to map the user requirements to the functional requirements, design specification and the IQ/OQ/PQ test script references.
Developed Change Control forms by determining the Technical Impact, Business Impact and developed the Change Plan to be executed for the Change Controls.
Developed the Validation Summary Report to provide a summary of the validation activities and executed deliverables.
Conducted the training of the business team Responsible for test script execution.
Archived all the validation packages using unique code identification in a centralized repository.
Catalent, St. Louis, MO 12/2016 to 04/2018
Validation Engineer
Project:Validation of Oracle E-Business Suite (ERP) and Oracle Financials Application (11.i) during Infrastructure upgrade. The software was being used for order processing, inventory control and monitoring, order tracking, customer management, employee data management to name a few. Activities Responsible forstallation, configuration, and data migration verification for the EBS database and application servers as well as testing the functionality of Oracle EBS application after the upgrade
Responsible as Test Coordinator during test execution activities including logging of test errors and management of Test Error Forms, review, and final disposition of executed test script.
Tracked compliance issues and defects using Track wise.
Gathered, finalized, and drafted the user and functional requirements.
Coordinated weekly status meetings with the end users and the core team to ensure timely delivery of the deliverables
System validation using GAMP guidelines to conform compliance with the FDA and 21 CFR Part 11 requirements.
Development of Verification Scripts for the Installation, Configuration and Migration of the Oracle EBS Validation and Production Environments.
Tracked defects and bugs using Mercury Test director.
Creation/drafting of technical documents for validation: Qualification plan, Test plan, UAT scripts, IQ and Data migration verification scripts, Test summary reports.
Development of System Test Script for design testing for fault-tolerance, load-balance and concurrent processing for Oracle EBS database and application servers.
Development of hardware verification, IQ, and data migration verification scripts.
Verification of installation, configuration, and data migration for Oracle EBS database and application servers during the upgrade, in the validation and production environments.
Development of qualification plan and test plans for installation, configuration, data migration verification and System/User acceptance testing.
Regression testing for Oracle EBS Financials and HR related functions.
Development of System/Functional Test Scripts for integrations /interfaces which includes inbound and/or outbound data (for non-Oracle products).
Development of test scripts for Oracle EBS integration with HR concurrent processes (Health benefits, transportation benefits, dental, vision, employee details and employee data)
Development of test scripts for Accounts Payable, Accounts Receivable, Cash management, Fixed Assets, General Ledger (Oracle Financials Application).
Development of scripts for internet procurement, internet expenses, purchase orders, concurrent processes and ADI.
Development of test scripts for OPM (Oracle Process Manufacturing).
Review and final disposition of the executed test scripts.
Development of Requirements Traceability Matrix and Test Summary Reports.
Archiving of the validation documentation for the application.
Testing, debugging and documentation of configuration activities in accordance with SDLC.
Creation and management of documents within documented tool, QDOCs
Project: Implementation of Aris Global Adverse Event Reporting System (AERS). This system provides a suite of solutions for Pharmacovigilance and Safety. Employs proactive surveillance programs and takes a long-term approach to manage the safety of drug products.
Responsibilities:
Actively participated in the requirement gathering sessions.
Analyzed and documented Business Requirements and developed Master Test Plan
Validated computer systems according to FDA regulations
Assisted Project Manager in maintaining a log of all Arisg-related issues.
Developed and reviewed Standard Operating Procedures (SOPs) for various functionalities of the system
Validated Arisg AERS for the imparted changes and updated the requirements documents.
Participated in various project teams in reviewing and approving a number of validation effort deliverables IQ-OQ-PQ protocol reports, Requirements Traceability matrix, and Discrepancy Report.
Involved in audits, Corrective Action and Prevention Action (CAPA), Change Control Process, investigations and Document Management Process.
Worked as Test Coordinator during execution of Change Control (Test Plans) and involved in pre and post QA review process of validation documents according to FDA regulations and GAMP.
Bio-Pharm Inc. Levittown, PA 10/2015 to 12/2016
Validation Analyst
Project: The project involved validation of the Pharmacovigilance Drug Safety Database System ArisG, a web-based application for Adverse Events Reporting System (AERS) and developing Validation Protocols and Summary Reports. The system also contained 3500, 3500A forms and generated MedWatch safety reports.
Responsibilities:
Gathered the User requirements and prepared the Technical and Business Documents
Developed Business flow Diagrams
Performed SystemIntegrationTesting to verify that the integration of different LIMS modules has been successful and reporting interface errors.
Configured the ArisG System using Oracle database at backend.
Executed testing of E2B and non E2B data elements by modifying/importing XML files to ensure system functionality and data mapping with respect to the Case Report Form (CRF) is as per ICH guidelines.
Collaborated with subject matter experts and business users to ensure the flow of data throughout the CRF satisfies the requirements for FDA regulations and EU regulations.
Conducted vendor audits to ensure that the system is in compliance with the regulatory guidelines set according to the industry standards.
Involved in 21 CFR Part 11 compliance assessments.
Performed Validation of Documentum 5.3-based document repository used to store regulatory data.
Understood the Clinical Trial Process along with various study configurations involved in the process.
Involved in carrying out detailed sessions with the Corporate Quality Team and Validation Team to setup a Change Request process for the project.
Involved in creating training material and Standard Operating Procedures (SOP’s).
Developed Requirements Traceability Matrix (RTM) to keep track of the changing requirements.
Coordinated system development, onsite/offshore/user acceptance testing (UAT), and defect resolution using HP Quality Center.
Maintained open communication and conducted peer review within the Technical Writer group to ensure standardization and quality deliverables across the program.
Wrote Test Summary Report (TSR) as well as Validation Summary Report (VSR).
Participated in preparing and presenting weekly presentations for the progress of the project.
CADILA HEALTHCARE LTD, INDIA 01/2014-03/2015
Validation Analyst
Responsibilities:
Responsible for interpreting results of validation test work in relation to Acceptable residue limits(ARL)
Prepared documents in compliance with 21 CFR Part 11 for Electronic Records, Electronic Signatures and Audit Trail
Conducted validation tests with minimal impact on operations
Responsible to maintain the validation status/protocol of critical cleaning procedures, computerized systems, equipment, processes and utilities
Involved in implementing qualitative procedures for cleaning validation
Responsible to provide cover and continuity for Customer Complaints, NCR / CAPA and any other task(s) for other members of the Quality Team due to absence or workload requirements
Responsible for understanding the Functional Requirements (FRS) and generating data request to the data coordinator
Responsible for client interactions for requirements issues and reporting the issues to the subject Matter Expertise (SME)
Prepared Traceability Matrix for Test Coverage using QC
Performed risk assessments on client’s validation processes and documented validation strategies, Risk Assessments as needed
Provided proposed validation improvement suggestions
Composed training files and prepared validation training courses for client employees and consultants
Validations reports summary should be prepared
Mylan Laboratories –Hyderabad, India 02/2013-11/2013
CSV Engineer (Intern)
Involved in preparing, executing and defending Remediation Plans, Change Controls, Requirements, Design Specs, Traceability Matrices, IQ, OQ and PQ protocols and summary reports for spreadsheets.
Experience validating PLC’s and Computer Systems.
Designed Performance Qualification for LabVantage LIMS by studying the business rules and interviewing the users.
Analyzed and reviewed validation deliverables like Validation Plan, Risk Assessment, Validation Summary Report in compliance with 21 CFR Part 11, GAMP 5 and GMP FDA Compliance
Involved in preparation of documents for Computer systems validation documents in accordance to 21CFR Part 11.
Implemented and managed Functional design requirements, design input and output (I/O), design Verification and Validation (V&V) and design risk management.
Worked in compliance with FDA regulations and cGxP guidelines in all the aspects of Computer Systems Validation.
Initiating CDP, machine procurement, Master validation, IQ/OQ/PQ Protocol writing, DOE to find out optimum parameter, machine installation and validation to prove the process capabilities and summary writing for manufacturing release
Defined and implemented risk-based validation strategy for various GxP applications for effective and efficient implementation according to applicable internal and external regulations.
Plan, develop and perform validation and qualification of packaging equipment, utilities and facilities (IQ, OQ, PQ, QRA, URS)
Responsible for general lab maintenance including daily, weekly and monthly cleaning of
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