PROFESSIONAL SUMMARY:

• Seven years of experience as IT Validation Lead/ Quality Assurance Specialist in pharmaceutical, medical devices industries including specialization in 21 CFR part 11 compliance and GAMP, GxP’s (GMP, GLP and GCP).
• Sound knowledge of Software development life cycle (SDLC) including Waterfall & Agile methodologies and Quality Management Systems.
• Expertise in Computer Systems Validation, Data Migration and Data Integrity, System Development Life Cycle, Validation Life Cycle, Testing methodologies, Deployment, SOP’s and Good documentation practices.
• Excellent experience in performing Gap Analysis and implementing Remediation activities.
• Excellent experience in reporting Quality Metrics to update management on testing progress.
• Develop moderate to highly complex protocols for validation projects using risk based approach meeting regulatory requirements.
• Expertise in creating and executing Computer System Validation Plans, protocols and validation test scripts and document test results in accordance with FDA standards.
• Excellent experience in driving Data Migration activities from Legacy Systems to new systems.
• Experience in performing stage gate reviews and assessing the cycle completion criteria (Test coverage, Cost, Software quality, etc..,)
• Experience in collecting reviewing and reporting the defined metrics.
• Experience in reviewing the QMS metrics data and providing recommendations for process optimization.
• Proficient in different phases of Testing like Black Box Testing, White Box Testing, Functionality Testing, Unit Testing, Integration Testing, System Testing, Backend Testing, Load Testing, Regression Testing and User Acceptance testing.
• Experience in leading small teams and collaboration with cross functional teams.
• Working knowledge on ANSI, AQL sampling techniques.
• Developed validation documents for JD Edwards Enterprise One 8.12 ERP, SAP ECC 6.0, Oracle EBS, Amazon web Services (AWS), Dynamic Object Oriented Requirements System (DOORS) SQL Scripts, CRM, Siebel Compliant Management System, and Laboratory Information Management System (LIMS) and TrackWise in accordance with 21 CFR Part 11 & GxP regulations.
• Good experience in performing validation and periodic reviews for clinical systems SAS GRID and Veeva eTMF and CTMS (SAAS).
• Experience in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA, MHRA rules and regulations.
• Developed and reviewed Test Plans, Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ), Test Summary Report and Requirement Traceability Matrix (RTM).
• Performed Periodic Review activities.
• Experience in performing Root Cause Analysis and Developed & implemented corrective action and preventive action plans (CAPA).
• Experience in preparing Risk assessment, Regulatory Assessment, Technical Assessment, Remediation Plan and Deviation Reports for FDA regulated environment.
• Excellent verbal, documentation and organizational skills.
• Ability to work both independently and in a team-oriented working environment.

CORE COMPETENCIES

• Analytical Thinking and Problem Solving
• Process and Equipment Validation
• Quality Assurance
• 21 CFR Parts 11, 210,211 and 820
• Building Collaborative Relationship
• Computer system Validation
• Product Lifecycle Management
• GAMP 5 and ICH 8, ICH 9, ICH 10 Guide lines

TECHNICAL SKILLS:

Tools: MS Office, MS Visio, MS Project, Origin (graphing & analysis), Minitab 17, HPALM, Ignite PLM, Teamcenter9, SmarTeam, MKS, HP ALM and ADDM Discovery .

Methodologies: Waterfall, V-Model, Agile

Validation Deliverables: System Assessments, URS, FS, CS, DS, VP, Data Integrity Assessments, Part 11 Assesments, Qualification Plan, Test protocols (IQ/OQ/PQ), RTM, SOP, WI, VSR.

PROFESSIONAL EXPERIENCE:

Confidential, NY

QA Validation Consultant

Responsibilities:

• Reviewed and approved end to end validation documentation for Centron Presidio REES, RegnU (Compliance Wire) and Veeva Vault eTMF to ensure compliance with company policies and procedures.
• Performed periodic reviews and authored periodic review reports for Veeva Vault eTMF, Centron Presidio REES, Nautilius LIMS, ASTRA 6 software and Empower 3 software.
• Performed and authored Part 11 Assessment and Independent data integrity assessments for Centron Presidio REES system, SAS GRID 9.4 and Veeva Vault eTMF.
• Hands on review of the following deliverables for all aforementioned systems - Regulatory Assessments, Risk Assessments, Validation Master Plans, Qualification Protocols, Design Reviews, User/Functional Specifications, IQ/OQ/PQ, Validation Summary Reports, Final Reports, Gap Analysis/Remediation Plans, User Manuals and Materials.
• Reviewed the IT tickets raised in service now for the above mentioned systems as a part of periodic review.
• Reviewed the executed qualification protocols for IDBS E-WorkBook Suite (ELN) v10.3
• Performed periodic reviews for laboratory equipment such as UPLC, Capillary Electrophoresis, Tecan Freedom EVO and Plate readers.
• Reviewed and approved documents using DocCompliance.
• Provide validation guidance to system Validation team to ensure compliance to FDA requirements.
• Proficient in GAMP 4 & 5, ISPE Baseline Guide for Commissioning and Qualification.
• Performed pre-approvals and post-approvals on IQ/OQ/PQ test cases and Defects.
• Reviewed and updated IQ/OQ/PQ Summary Reports, Validation Final Reports and Go Live memos.
• Participated in Webinars related to data integrity and Audit trials.

Confidential, Illinois

QA Validation Lead

Responsibilities:

• Analyzed and implemented the Company’s Computer Systems Validation Policy and Computer Systems Change Control Policy.
• Initiating change controls to implement the changes in the systems
• Authored the validation/compliance strategy for Baxter- AWS Cloud implementation
• Performed the validation of Infrastructure for Web application hosting (WAH)
• Conducted Business Workshops and participated in requirements gathering meetings.
• Carry out effort estimations, test planning execution and defect management activities
• Reviewed and updated User Requirements Specifications, Functional Requirements Specifications and System Design Specifications.
• Developed, reviewed and approved Test Plans, Test Strategies and Test Execution Mechanisms.
• Participated in Software Environmental Landscaping.
• Actively participated in Daily defect & Test execution meeting across various business teams and provide relevant status, associated risks updates and resolutions for the issues.
• Managing defects to drive through the resolution and conduct issue triage meetings as needed.
• Supervised the process to align the QA guidelines for different teams to ensure improved product quality.
• Performed 21 CFR Part 11 Assessment and Computer System Validation Risk Assessment
• Participated in developing, monitoring and Maintaining Data gathering, cleansing and import/export in different formats.
• Developed Test Plan and Test Cases.
• Developed Traceability Matrix.
• Performed Business User Acceptance Testing for verification of business rules.
• Reported defects to Quality Centre and tracked till closer.
• Designed and documented all the issues and defects to ensure application software functionality for present and future releases.
• Communicated effectively with development team on bug/defect reports with proper analysis and with reproducible scenarios.
• Responsible for weekly status meetings showing progress and future testing efforts to QA Manager.
• Experience in using BPLM and TcU as Documentum to route the documents for approval
• Involved in the Change Advisory Board (CAB) meetings to discuss the GxP impact of new change requests and the compliance risk level associated with the change.

Confidential, Pennsylvania

QA Validation Specialist

Responsibilities:

• Supported the implementation and contributed in the creation of program SOPs and WIs to ensure compliance with computer system standards.
• Identified quality user requirements and ensured the successful implementation of SAP across all sites in the region per global programs.
• Developed Validation strategy using risk based validation approach and documented in Validation Plan.
• Established and maintained processes to assure the implementation of a compliant and effective SAP program across the network.
• Reviewed and approved the test scripts for new SAP transactions, customized transactions, tables using the HP ALM.
• Used HP ALM for review and approval of the executed test scripts
• Prepared a Defect Status Report from the HP ALM for all the pending defects, Also Reviewed and approved the pending defects as per the standard operating procedures of Confidential Pharmaceuticals
• Used Smart-Team and Smart View Applications for reviewing and uploading the Client’s Validation documents.
• Reviewed and approved the Change Requests in Mortice Kern System (MKS).
• Ensured compliance with all applicable GxP regulations, policies and procedures related to Information Technology and computer systems
• Supported in the preparation for various regulatory inspections focusing on site preparations as well as participate in remediation efforts for observations identified during FDA and internal audits
• Attended daily meetings with the compliance team regarding the status updates of the project

Confidential, California

QA Validation Engineer

Responsibilities:

• Preparation of testing timeline and testing approach based on the requirements and scope.
• QA deliverables and guiding team members on agile standards and best practices.
• Regularly interact with management and product owners on project status, priority setting and sprint timeframe.
• Established and reviewed QA sign off criteria, software build and test process with scrum team.
• Experience working in Data Extraction, Transformation and loading from source to target system.
• Ensuring the accepting criteria is met for each product increment at the end of iteration.
• Effectively lead issue triage meetings with scrum team to plan defect fixes for sprints by reviewing the defect priority and severity with Product owner.
• Creation of test scenarios for UAT testing.
• Developed Test Plan and Test Cases.
• Developed Traceability Matrix to ensure complete coverage of requirements.
• Performed Business User Acceptance Testing for verification of business rules.
• Reported deviations to Quality Center and tracked till closer.
• Designed and documented all the issues and defects to ensure application software functionality for present and future releases.
• Communicated effectively with development team on bug/defect reports with proper analysis and with reproducible scenarios.
• Responsible for weekly status meetings showing progress and future testing efforts to QA Manager.

Confidential

Jr. Executive, QA

Responsibilities:

• Validated various production equipment and processes like vial washing, vial filling, Autoclave and stopper processing in Terminal Sterilization.
• Developed and executed validation protocols and evaluated validation results of validation protocols for production processes, equipment, and system in compliance with internal and external requirements.
• QA/QC of validation documents, periodic calibration records of manufacturing equipment and reporting non-conformances.
• Refereed the URS, FRS and FAT for the development of SAT, IQ, OQ and PQ of the production process and equipment.
• Executed SAT, IQ, OQ, PQ and cleaning validation for Solution preparation, Vial washing and Stopper processing equipment.
• Carried out the area qualifications for the clean rooms.
• Tracked and reported validation progress of corporate validation projects through departmental project tracking tools.
• Verification of SOPs to accurately describe the process employed in the validation study.
• Involved in root cause analysis for discrepancies observed during the execution of IOQ and PQ.