SUMMARY

• Over 8 years of extensive experience of all the aspects of Software Validation, Testing Life Cycle, with emphasis on manual testing.
• Expertise in all the stages of the software development life cycle (SDLC) and QA methodologies.
• Excellent experience working with Documentum (Document Management System).
• Gained experience in Load, Stress, Performance, Regression, Smoke and System/end to end testing.
• Excellent working knowledge of Computer System Validation (CSV), developing and reviewing Installation Qualification(IQ), Operational Qualification(OQ) and Performance Qualification(PQ).
• Proficient in dealing with Standard Operating Procedures (SOP's), Test Plan, Laboratory Management System(LIMS).
• Configured, Commissioned and Validated Labware LIMS, Crystal report.
• Experience in developing Requirement Traceability Matrix (RTM).
• Competent in Quality System and Standard (cGLP, cGMPs, and cGMPs), 21CFR (Part 11, QSR, Gap Analysis and Remediation Plans.
• Good Knowledge in 21 CFR Part 11 tool kit. Reviewed projects to determine regulatory and compliance impact.
• Proficient in manual and automated testing, wrote and designed validation master plans, test cases, test scripts, Test strategy and test procedures.
• Strong Analytical Skills with high level of energy and creativity also a quick learner and committed to continuous self - improvement.
• Excellent communication and presentation skills and can work efficiently in teams and independently as well.

TECHNICAL SKILLS

Validation: 21 CFR Part 11,cGXP(cGMP,cGDP, cGLP), GAMP, GCL GPV Quality System Regulation (QSR), Audit Trails, Standard Operating Procedures (SOP's), Gap Analysis and Remediation, Validation Plan and Protocols, RTM, Risk Management.

Software Applications: LIMS, MYQUMAS, EQMS

Testing Tools: HP Quality Center/ALM

Operating Systems: Windows 2012/XP, Windows 8.

Business Tools: MS OfficeSuite 2010 &2016, MS Project & Visio.

PROFESSIONAL EXPERIENCE

Confidential, Minneapolis, MN

Validation Lead

Responsibilities:

• Prepared Validation Master Plan (VMP) for validating LabWare LIMS.
• Interacting with Managers and gather requirements and updated URS Document.
• Authored Functional Requirements Specifications (FRS) and System Configuration Document for all the modules of LIMS.
• Created and authored documentation for all aspects of the computer systems validation lifecycle in accordance with FDA regulations, particularly 21 CFR part 11, including: Validation Plan and Protocols for Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) and Validation Summary report (VSR).
• Authored Environmental Monitoring and Manufacturing Data Migration protocol and individually prepared a Data Migration Summary report.
• Created and updated System Requirements Design Test Matrix (SRDTM) with all the qualification activities performed in the Phase II and updated Phase I requirements.
• Configuring Reports of LIMS using SAP Crystal Reports Developer.
• Wrote Working Instructions for various modules and assisted in drafting the Standard Operating Procedures (SOP).
• Created Training Material of General Use of LIMS for the end users including all the above-mentioned modules.
• Accountable for documentation of Computer System Validation Deliverables in accordance with 21 CFR Part 11
• Performed Risk Assessment and authored the document.
• Performed ERES risk assessment for electronic records and electronic signatures to assess 21 CFR Part 11 applicability and compliance.

Confidential - Warsaw, IN

Validation Engineer

Responsibilities:

• Part of the validation and compliance group at Medtronic
• Reviewing new projects from regulatory standpoint. Ensuring part 11 assessment gets completed in the tool kit and review of all evidences and evaluations done before going live of projects.
• The company uses Labware LIMS. Involved preparing documentation for validation of LIMS as per 21 CFR Part 11 and FDA regulations.
• Involved in validating Laboratory Information Management System (LIMS)
• Involved in gathering and documenting User Requirements and developing Validation Master Plan
• Conducted vendor audits and was in charge of the computer systems software validation part of Labware (vendor for LIMS).
• Completed 21 CFR Part 11, GxP and Functional Risk Assessment for the system.
• Developed Validation Plan to outline activities, deliverables and roles and responsibilities.
• Responsible for review and approval of validation documents including but not limited to Validation Plan, Installation Qualification Protocol (IQP), Operational Qualification Protocol (OQP), Performance Qualification Protocol (PQP), Test Plans, Traceability Matrix, Validation Registry Checklist and Validation Summary Report.
• Develop and verify Periodic Review plan, Back-up and Disaster Recovery plan and Change Control plan for post-deployment support.
• Attended requirements gathering sessions, reviewed System Design Specifications and System Baseline Configuration.
• Created Testing Documentation including Test Plan, Test Cases, Test Scripts, Requirements Traceability Matrix (RTM), Defect Report and Test Summary Report.
• Used Quality Management tools such as HPQC to manage requirements, test plan, test scripts and defects.
• Managed defects by ensuring that proper documentation and corrective actions have been implemented.
• Reviewed Requirements Traceability Matrix to ensure that all the requirements are appropriately tested in designated test phases.
• Closely worked with business representatives to provide guidance on creation of User Acceptance Test (UAT) scripts during implementation.
• Review and approvals of execution of IQ, OQ and PQ Scripts.
• Summarized Validation activities, test results, and open issues in the Validation Summary Report.

Confidential, Chicago, IL

Validation Engineer

Responsibilities:

• Part of the validation and compliance group at Hill Rom as consultant.
• Part of Quality and regulatory program at Confidential .
• Individually handled User acceptance testing of Mercury reporting module, which is the customer feedback management system.
• Authored all validation deliverables like Validation Plan, UAT protocols, UAT summary report, Validation summary report.
• Worked closely with IT as well as Business groups.
• Document review for used cases, business requirements, as well as system integration test protocols.
• Excellent experience working with Documentum (Document Management System).
• Gained experience in Load, Stress, Performance, Regression, Smoke and System/end to end testing.
• Excellent working knowledge of Computer System Validation (CSV), developing and reviewing Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Proficient in dealing with Standard Operating Procedures (SOP's), Test Plans.
• Involved in developing Requirement Traceability Matrix (RTM).

Confidential, Franklin Lakes, NJ

Validation Engineer

Responsibilities:

• Responsible for developing all key validation deliverables- Requirement Specification documents, Risk Assessments, IOPQ protocols, IOPQ Final Reports.
• Worked with business users to gather the user, functional and security requirements for system.
• Worked as a user to test the functionality of system as part of UAT to be compliant with FDA regulations.
• Created and coordinated the execution, review and closure of multiple Change Controls for SAP.
• Coordinated with cross functional teams for generating the required objective evidence for SAP Change Controls.
• Developed Failure Mode Effect Analysis (FMEA) based risk assessment in support of the RCA for SAP Upgrade failure.
• Developed/Maintained the Traceability matrix, Discrepancy log reports for system.
• Created IQ, PQ scripts for system.
• Developed the IOPQ final reports for SAS application.
• Reviewed, updated and approved the executed PQ test scripts for SAS and SAP applications.
• Trained the business owners and implementation team on Good Documentation Practices and Validation Overview.
• Conducted manual testing, compared actual results with expected results and reported defects.

Confidential

Validation Analyst

Responsibilities:

• Leak Tester equipment is used to check whether there is any leakage in bottles or not for defectiveness.
• Several other factors like bore diameter, total diameter, capping performance, wall thickness, height weight, packing etc are checked for a HDPE bottle for Quality Control.
• Excellent background in supplier/customer complaint investigation, performance reporting, tracking/trending, and final determination of corrective actions.
• Worked for CAPAs and Non-Conformance Reports, NCRs, at HDPE manufacturing environment to meet ISO quality standards.
• Facilitated flow of products through inspection process, which minimized bottlenecks and delays.
• Responsible for new supplier development for new & existing product programs.Prepared PPAP checklists, approving and signing off supplier PPAP’s for new product programs.
• Developed/revised Standard Operating Procedures (SOPs), Work Instructions, BOMs, Process Flow Charts, FMEAs, Control Plans and Inspection plans criteria to outline for reference use in blueprints, drawings and specifications.

Confidential

Validation Engineer/Systems Analyst

Responsibilities:

• The project involved in performing the periodic reviews of the computer servers.
• Gathering all the documentation like the IQ/OQ/PQ, change controls, validation plans, summary reports for each server.
• Analysis of these documents along with system owners.
• Following a standard procedure of the company to check for compliance of these documents with the latest standards followed in the company.
• Same procedure followed for dealing with infrastructure compliance checking.
• Preparation of the final periodic review document.