Shonak

Employer Details

Swathi

469-***-****

ac48lf@r.postjobfree.com

IT Validation Engineer

Professional summary

Over all 9+ years of experience as in Pharmaceutical, Manufacturing and Biotechnology industries as a Software Test/Validation Engineer in Computer Systems, Bioinformatics, biotechnology, bioengineering, Medical Device, Software Validation and Quality Management.

Experience in Black/White Box, User Acceptance Testing, Functional, and Regression testing and complete End to End Testing.

Thorough knowledge about pharmaceutical/medical device regulations like FDA 21 CFR Part 11, part 820 and on ISO 13485/Part 820 / ISO 14971

Expertise in various SDLC methodologies such as Agile, Scrum and Waterfall in creating various protocols for DQ, IQ, OQ and PQ in compliance with GxP and company Standard Operating Procedures

Successfully worked with sustainability team to follow Lean six sigma manufacturing

Expertise in preparing User and Functional requirement specification documents for general validation and additionally validating LIMS applications.

Experience in developing test plans (i.e. integration, stress and UAT) schedules, test cases, scripts, execute tests, evaluate and review test data and Requirement Traceability Matrix

Develop, maintain, and monitor the implementation of the Document Control system across the contracts and different stake holders to provide a platform for consistent storage, distribution and archiving of engineering and construction related documentation

Experience in validation and testing documentation Validation Plans/Summaries, Test Plans/Summaries, URS/FRS, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and scripts

Experience in writing and executing Commissioning documents and IOPQ protocols and test procedures for implementation of an upgraded BAS system monitoring HVAC Systems.

Experience in Change Control management and tracking changes in TrackWise Change management module for better managing of the IT Quality Systems in compliance with GxPs

Expertise in validating LabWare LIMS and integrating LIMS with MES and ERPs such as SAP and Oracle EBS

Experience in defect identification in JIRA and tracking using applications such as GIT and HPALM

Experience in generating performance graphs, session reports and validation and analysis reports

Proficiency in reviewing existing SOPs for compliance with GxPs and developing new SOPs and making Project Plans

Experience in developing Validation Master Plans and System Test Plan, Risk Assessments Plans and Risk Management Plans to ensure quality of the computer system and medical device functionality

Technical skills

Validation

21 CFR Part 11, cGXP (cGMP, cGDP, cGLP), GAMP, Quality System Regulation (QSR), Audit Trails, Standard Operating Procedures (SOP's), Process Improvement, Quality and Inventory Management, FSD Creation, Quality Management, Risk Management, DCR, Document change control,Clinical development

Tools

HP Quality Center, Quick Test Professional HP QTP/UFT (Unified Functional Test), Win Runner, Test Director, NVDA and JAWS tools,ITIL, Tivoli Workload scheduler, Microsoft Coded UI, Microsoft Test Manager, Clear Quest, Clear Case, UML, ISO 13485 and ISO 14971

Application Software

Documented, Software Quality Assurance (SQA), MS Sharepoint

Databases

Oracle, MS Access, SQL Server 2000

Operating Systems

Windows 95/98/2000/XP and UNIX

Languages Business Tools

C, C++, PL SQL, MS Office Suite 2010

Professional Experience

Genentech Nov’17 – Till Date

Validation Lead

South San Francisco, CA

Responsibilities

Perform validation of identified operational and compliance risk controls to ensure they have adequate governance, evidence of execution, and appropriate monitoring and escalation.

Lead periodic review Process of verifying the validated state of the system and document its Report.

Developed critical validation lifecycle documentation to support the qualification/validation of equipment, processes and facilities (e.g.IQ, OQ and PQ protocols, Operational SOPs, PM SOPs, Change Controls, User/Functional/Design Specifications, etc) for client-related programs

Wrote procedures, investigations, System Test protocols, Design Validation Protocol, reports change controls, etc. to support client programs.

Gathered business requirements using UML, process flows and uses cases.

Support validation life cycle activities by commissioning, continuous process monitoring, change controls, SOP generation, and revalidation activities.

Experienced with Labview

Demonstrated proficiency in conducting risk management activities including but not limited to DFMEA, PFMEA, UFMEA, hazard and risk mitigation related to implantable medical devices and surgical instruments.

Experienced in APQP, PPAP, FMEA, SPC, MSA, control plans and ISO & TS 16949.

Assist engineering with equipment qualifications by participating in FATs, commissioning activities, SATs, and IOPQ events.

Lead for a new Automation Building Management System (BMS) for HVAC controls.

Operations building systems using Computerized BMS (building management systems) sets up trends of HVAC and equipment to maximize efficient use of equipment and energy.

Wrote process risk assessment through PFMEA

Ensure risk management tools are employed and evolving (HARA, DFMEA, PFMEA). Oversee and ensure risk assessments adequately address safety and efficacy and are compliant to the highest standards. Promote a “safe culture”

Experience on QSR, GMP, Statistics, Validations, IQ/OQ/PQs, PPAP, APQP,DOE,FMEA,ISO 9000,QS-9000,ISO 14001 and ISO 13485

Development of programs to comply with both customer and internal requirements as identified during the APQP and PPAP processes

Performs and documents timely Corrective and Preventive Actions (CAPA) investigations.

Acts as lead on assigned CAPAs to drive corrective actions and closure of CAPA within prescribed timelines.

Worked on End to end testing in Stem Cell Therapy project involving deep understanding and all VDLC documentation.

Provide input for PFMEA, Control Plan and Process Flow

Experience in applying Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements

Routed computerized systems documents (Validation Project Plan, URS, TM, IQ, PQ, UAT, Vendor Postal Audit Report, Computer System Risk Assessment, Periodic Review Report, Decommission Report, SOPs, and Validation Summary Report) using SAP and eDOCs for review and approval.

Provide computer systems validation support for electronic quality management systems, spreadsheets, databases and other systems subject to 21CFRPart 11 requirements.

Followed Computer Systems Validation CSV Master Plan to author, review and approve CSV deliverables for systems as per GxP GLP, GCP, GMP, GDP, cGMP FDA Assessment.

Authored, reviewed and approved CSV deliverables Validation Project Plan, URS, TM, IQ, PQ, UAT, Vendor Postal Audit Report, Computer System Risk Assessment, Periodic Review Report, Decommission Report, and Validation Summary Report for TempTale Desktop Manager used by the Supply Chain.

Analyzed Computer System Validation documents including User Requirements (URS) and

Closely worked with Subject Matter Experts (SME's) and Computer System's Owners (CSO) for gathering the requirements.

Environment: 21 CFR Part 11 LS COTS products (Trackwise, Documentum, LIMS, LMS, CTMS )HPQC, MS word, Excel, Lab view, Trackwise, Documentum

Otsuka Pharmaceuticals Oct’15-Oct’17

Validation Lead

San Francisco, CA

Responsibilities

Managed the Onsite/Offshore model and the offshore team of eight people including distribution of tasks and Project plans etc

Executes equipment qualification protocols and accurately document results of the defined testing; then comparing and reporting those results to predefined/approved acceptance criteria

Responsible for all Software programming (Csharp), Installation, Testing, Troubleshooting and other related activities

Organizing and presents qualification data, results, documentation and reports within the appropriate equipment/system validation files and system manuals.

Validating and testing documentation such as Validation Plan Summaries, Test Plans Summaries, URS and FRS, RTM, Qualification Protocols and scripts, Testing Defects

Collecting and organizing technical specifications, data and information required for client projects.

Responsible for process and equipment risk management PFMEA / RA

Creating, Executing and Maintaining Test Scenarios, Test Cases and Manual test scripts based on the Business Requirements and Workflows

Prepared, executed qualification protocols: FAT, SAT, IQ, OQ, PQ and PFMEA studies.

Involved in Regression testing, when new features are added and fix bugs

Involved in documentation of technical manuals, data flow diagrams, requirement documents etc.

Formulating protocols for PQ, IQ, OQ, DQ, servers and network infrastructure devices and routers

Conducting testing such as developing test plans (i.e., integration, stress, and UAT) and schedules, test scripts, test data, use cases, and roles and responsibilities, Microsoft Test Manager and related APIs to integrate with Visual Studio

Environment: 21 CFR Part 11 LS COTS products (Trackwise, Documentum, LIMS, LMS, CTMS )HPQC, MS word, Excel, Trackwise, Documentum, Quality Center, Agile, Argus

Sanofi Mar’14 – Sep’15

Validation Lead

Bridgewater NJ

Responsibilities

Formulating protocols for DQ, IQ, OQ, PQ, servers and network infrastructure devices and routers

Preparing documents for regulatory submissions in accordance with per FDA 21 CFR Part 11

Preparing documents for CFR Part 11, GAMP 5, EU annexe 11, IDMP and FDA UDI guidelines

Designing & developing Automation Test Strategies

Reviewing equipment manuals, specifications, drawings and operational documents to ensure validation and qualification protocols and standard operating procedures are in-line with manufacturer's specifications, operational procedures, calibration requirements and required maintenance

Validating and testing documentation such as Validation Plans Summaries, Test Plans Summaries, URS and FRS, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and scripts, Testing Defects

Working with Quality Control and IT personnel to design, draft and validate qualification protocols

Working with Agile Dual Track Scrum methodology and ability to create automated test scripts and knowledge on data integrity requirements

Data setup, data creation, test data and data mockup for Flat File, Data bases and Mainframe files

Creating complex SQL statements for data base verification and validation

Attending to Fed reporting using applications Enhanced Prudential Standards Projects and Dodd

Conducting testing to ensure accurateness of data, compared to the source

Creating, Executing and Maintaining Test Scenarios, Test Cases and Manual test Scripts based on the Business Requirements and Workflows

Processing customer requests for data migration management

Providing the necessary documentation and reporting to track and record the status of testing, monitoring, maintaining and documenting test results

Providing support to Medicaid with regards to the integration and validation of the legacy Medicaid system into the Modernized Medicaid Eligibility System

Responsible for quality assurance of process, application testing and defect tracking

Developing and reviewing System Test Plan, Risk Assessments, Risk Management Plan and Risk based validation.

Involved in reviewing and maintenance of Oracle EBS supply chain modules and exposure to ERP & CRM

Environment: 21 CFR Part 11 LS COTS products (Trackwise, Documentum, LIMS, LMS, CTMS )

HPQC, MS word, Excel, Trackwise, Documentum, Quality Center

Alcon March 12 – Feb 14

Validation Consultant

PA

Responsibilities

Identify emerging risks, process improvements, or areas for increased training through the analysis of results.

Reviewing equipment manuals, specifications, drawings and operational documents to ensure validation and qualification protocols and standard operating procedures are in-line with manufacturer's specifications, operational procedures, calibration requirements and required maintenance

Preparing documents for CFR Part 11, GAMP 5, EU annexe 11, IDMP and FDA UDI guidelines

Developing test plan, test cases and test scripts to validate production and planning

Working with Quality Control, Information Technology, and Facilities personnel to design and draft validation and qualification protocols

Working with end users in the evaluation and implementation of MES application updates and changes

Writing user and functional system requirements for Laboratory Information Management Systems (LIMS) and integrations between LIMS and ERPs such as SAP, Oracle EBS

Involved in Regression testing, when new features are added and fix bugs

Creating, Executing and Maintaining Test Scenarios, Test Cases and Manual test Scripts based on the Business Requirements, Workflows

Developing and maintaining Requirement Traceability Matrix (RTM)

Involved end to end manual testing of the application and Performing configuration testing

Generating SQL Queries in document Administrator to run the audit trail reports

Participating in discussions for validation approach meetings, technical meetings, user group meetings and project status meetings

Environment: Virtual Link Manager, HP Quality Center, Trackwise, Windows XP/7,Live Link, EDMS, MS office suite, Oracle 11g, E-Work Book System, Documentum, SharePoint

Biogen June 09 – Feb 12

Validation Engineer

MA

Responsibilities

Responsible for analyzing and reviewing validation deliverables like User Requirement specification and Functional requirement specification

Developing OQ and PQ test scripts for Stability, Lot Management, Product Specifications, Test Methods, inventory management and report modules to meet approved requirements

Involved in documentation of technical manuals, data flow diagrams, requirement documents etc.

Performing manual testing on system before sending it to automated testing and updated reports on testing on Quality Centre

Conducting testing such as developing test plans (i.e., integration, stress, and UAT) and schedules, test scripts, test data, use cases, and roles and responsibilities, Microsoft Test Manager and related APIs to integrate with Visual Studio

Involved in the review and design of test cases, process change requests, analyze and map process

Developing Traceability Matrix to track the requirements during the QA Testing Phase

Developing traceability matrices, deviation forms and validation summary reports (VSR)

Environment: Tomcat 6.0, Crystal reports, 21 CFR Part 11, MS word, Excel, Documentum, Quality Center, Agile, Oracle SQL Developer, Oracle Database, MS Project plan

Abbott Laboratories Aug 08 – May 09

Validation Engineer

IL

Responsibilities

Reviewing business requirements and functional requirements for validation projects

Developing data migration plan and performing data mapping from source to target fields

Developing Crystal report templates for Trackwise

Developing test cases and scripts for validating LIMS and Documentum

Writing user and functional system requirements for Laboratory Information Management Systems (LIMS) and integrations between LIMS and ERP (SAP), and LIMS and CDS (Empower)

Conducting requirement analysis and design walkthroughs sessions with relevant users

Preparing Requirements, Functional Specification and Trace Matrix documents

Preparing Dashboard to keep Trackwise of the test activities

Creating IQ's, OQ's, and PQ's documents and make sure were approved by assigned signatories

Involved in reviewing and modifying and creating new qualification protocols

Environment: Quality Center, GxP, Microsoft Office tools, Oracle, Crystal reports

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