SUMMARY

• 20 years of diverse experience in Verification and Validation, Computer System Validation, Business Systems Analysis, Design Validation, Process Validation, Test Method Validation, Product Validation, Risk Analysis and Software Quality Assurance in Medical Devices, Biotech and Pharmaceutical industries.
• Broad range of knowledge and experience in regulated environments: ISO 13485: 2003 Medical Device Quality Management System Requirements, FDA 21 CFR Part 820 Quality System Regulations, 21 CFR Part 11 Electronic Records, Electronic Signatures; EU Annex 11; EN ISO 14971:2012 Risk Management, IEC 62304 Medical Device Software - Software Life Cycle Processes, IEC 60601 Medical Electrical Equipment, IEC 62366-1:2015, Medical Devices - Application of Usability Engineering to Medical Devices; GLP: 21 CFR Part 58; GCP: 21 CFR Parts 50, 54, 56, 312, 314, 320, 601; GMP: 21 CFR Parts 210, 211, 820; GDP: USP Chapter 1083; GPvP: Pharmacovigilance Guidelines EudraLex Vol. 9; Drug Marketing: 21 CFR Parts: 203, 205; Pharmaceutical Quality System: ICH Q8, Q9, Q10; MDD 93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, IVDD 98/79/EC, PIC/s, GDPR, EU MDD/MDR, CGMP, ISPE, GAMP5, EU, CMS CLIA/CAP, ALCOA, CGHTF, SOX, SEI CMM, IEEE, IEC/EN/AAMI, CE mark, FDA 510(k) submission.
• Strong expertise in creating, generating and executing Business Requirements, Business Reports, Status Report, Functional Specifications, Blue Print Documents, Test Plans, Test Cases, Test Procedures, Test Strategies, Test Reviews, Test Summary Reports including discovery, blueprint, design, configuration, development, realization, functional testing, unit testing, system testing, Business Integration Testing (BIT) and User Acceptance Testing (UAT).
• Hands-on experience in Class II and III Manufacturing, Industrial Engineering, Process Engineering, Quality Engineering, Packaging Engineering, Supplier Controls, NCR (Non-Conformance Reporting), Design Controls, Risk Management, Root Cause Analysis, Change Controls, Supplier Controls, CAPA, FMEA, Medical Device Reports (MDR), Adverse Drug Events (ADE's) and Complaint Handling and Reporting, CCB (Change Control Board) and MRB (Material Review Board)

TECHNICAL SKILLS

• Validation & GxP assessments, FDA QSR, 21 CFR Part 820.30, 21 CFR Part 11, IEC 62304 Software Life Cycle Processes, ISO 9001, ISO 13485 Quality Standard, SEI's CMM, Vendor Audits, Siebel CRM and CTMS, ClinPlus CTMS 2.2, Allegro CTMS, DOORs, PLM (Arena PLM, Enovia, PTC Windchill, SAP PLM, Oracle Agile PLM-PPM, PQM, PCM, Confidential &C, EC); SDLC, QAAD Quality Management; MES (Camstar, RockWell FTPS, Werum PAS-X, STARLIMS, TrakSYS); LMS (Saba, Plateau 6.3, ComplianceWire), BioFortis, OpenText, Filenet, Firstdoc, FirstPoint, NextDocs, Documentum, Captiva InputAccel, Veeva Vault (CTMS, eTMF, RIM, EQMS, CRM), SmartSolve, InSight, Livelink/OpenText, Sharepoint, Argus, ARISg, Oracle AERS, BioClinica, Jira, Confluence, Jama, ERP/CRM (SAP, Oracle EBS, Microsoft Dynamics, JD Edwards, NetSuite, Salesforce), Concur, Coupa, HCM: ADP Workforce Now, Infor, Kronos, Workday, SuccessFactors; EQMS (TrackWise, 123Compliance, MasterControl, Veeva, Arena, SmartSolve, CATsWeb, ValGenesis); LIMS (LabWare, LabView, StarLIMS, Labmatrix, Waters NuGenesis, LabVantage); GAMP 5, cGMP, GLP, GCP, Dicom, HIPAA, Embedded, Change Control & Configuration Management of cGxP sytems
• Master Validation Plan, Project Plan, Risk Management Plan, Data Migration Plan, Risk Analysis & 21 CFR Part 11 Assessments, User/Functional Requirements, IQ/OQ/PQ Protocols, IQ/OQ/PQ Summary Reports, SOPs, Design Specs, Test Case Authoring, Execution of Test Cases, UAT Test Cases, Requirements Traceability Analysis and Matrix, Regression Impact Analysis, Change Logs, Testability Analysis, Test Summary Logs, Information Protection Plan, Training Plan, Document Management, Gap Analysis, CAPA, FMEA, Change Control, ERES Assessment, DHF, DHR and DMR.

PROFESSIONAL EXPERIENCE

Confidential

Validation Program Lead

Responsibilities:

• Leading Thermo Fisher CMD Quality Compliance and Validation for new and existing GxP systems including IT infrastructure, servers, process equipment and information systems per current FDA, ISO, GAMP, GxP, GMP, FMEA, PHP, ICH Q7, Q8, Q9, Q10 and other US and international regulatory requirements and guidelines.
• Providing design control and software/systems development guidance to Confidential mass spectrometry software development teams to be the single point representative for Design Quality Assurance activities.
• Provided direction and leadership from within the Regulatory Compliance group to R&D, Quality, Operations and Regulatory Affairs to ensure products are developed in conformity with applicable global external regulatory requirements and standards and maintain conformity throughout their commercial lifecycle.
• Supporting development and qualification of medical device software, embedded firmware aspects of design input, design outputs, design verification, design validation, design changes, design transfer and DHF.
• Performing as SME on implementation and validation of Veeva QMS (CAPA, Complaints, Deviations, Change Control, Document Control) ensuring implementation plans, CSV, UAT to complete and qualify a system within given constraint of scope, time and schedule.
• Leading all validation and testing activities on implementation of Oracle EBS Cloud Supply Chain Management and Finance modules and its integrations with Salesforce, LIMS, MES, Veeva Vault Suite (CTMS, eTMF, RIM, CRM).
• Performing as hands-on Validation Engineer authoring and executing SDLC deliverables such as URS, SRS, FRS, DDS, RTM, Unit, Integration, Commissioning Protocols, Manufacturing Equipment Qualification, UAT, Delta V, FAT, SAT, Validation Planning, IQ/OQ/PQ and Validation Summary Report.
• Providing quality and compliance oversight for computer system validation and electronic records/electronic signatures compliance programs and performing 21 C FR Part 11 and Annex 11 assessments (gap analyses) to assist business areas and IT developing corrective action plans.
• Gathering and validating business needs to translate into business requirements to document Business Requirement Document (BRD) and transform the same into System Requirement Specification (SRS) and Functional Requirement Specification (FRS).
• Applying GAMP 5 risk based approach for risk based validation to determine the scope of validation for GxP systems to develop documentation and validation activities with appropriate justification of the approach.
• Performing FDA 21 CFR Part 11, 820, 210, 211 and EU Annex 11 Gap assessments to assure that the business process is improved and efficiency increased while creating GxP compliant computerized systems.
• Assisting SAT/UAT team to execute test cases, and analyze the results. Support tracking of issues and enhancements. Developing User Training manuals for applications and conduct training workshop for the users.
• Providing QA oversight and assessment for GxP computer systems related deviations, CAPA and change controls to apply risk based methodology to validation efforts.
• Participating in Change Control Board (CCB), reviewing proposed change control, assisting in the validation impact assessment regarding to the changes, generating testing to ensure and document that GxP systems are maintained in the validated state in production.

Confidential, Foster City, CA

IT Systems Validation Lead

Responsibilities:

• Designed, coordinated and executed Oracle EBS DR (Disaster Recovery) annual test exercises for the enterprise integrated applications of Oracle E-Business Suite.
• Performing Business analysis, requirement gathering and testing of Oracle EBS Cloud enterprise integrated applications. Retained post-implementation to transition the IT team to maintenance mode.
• Prepared Disaster Recovery Standard Operating Procedures and plans, managing IT Disaster Recovery Program partnering with the cross-functional Network/Security/Platform/Database/Application Production Support teams in all aspects of Disaster Recovery.
• Authored, executed and reviewed CSV documents: Validation Project Plans, User and Functional Requirements, Design Specifications, Data Migration Plan, Validation Traceability Matrix, Risk Management tools, GxP and Electronic Records (ER) / Electronic Signature (ES) assessments, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, Enhanced Design Reviews, Final Reports and Deviation Handling.
• Performed integration testing that covers business process transaction flow between Gilead Oracle EBS Ecosystem and its boundary applications to be in compliance with GAMP 5 Risk Based approaches, GMPs, Data Integrity, 21 CFR Part 11 and Annex 11 regulations (Electronic Records and Electronic Signatures), guidance for software IQ/OQ/PQ and Standard Operating Procedures.
• Identified in-scope boundary applications for Oracle EBS integration testing for GxP systems: EBS, GEM, OAM, LIMS, Argus, Gilda and non-GxP systems: Brainware, Kronos, GShip, MES, AssureNet, Model N, OBIEE.
• Tested business processes covering Plan to Make (PTM), Procure to Pay (PTP), Order to Cash (OTC), Order to Report (OTR), Account to Close (ATC), Shipping Execution (WSH), Warehouse Management System (WMS).
• Applied GAMP 5 risk based approach for risk based validation to determine the scope of validation for GxP systems to develop documentation and validation activities with appropriate justification of the approach.
• Performed FDA 21 CFR Part 11, 820, 210, 211 and EU Annex 11 Gap assessments to assure that the business process is improved and efficiency increased while creating GxP compliant computerized systems.
• Provided an oversight and assessment for GxP computer systems related deviations, CAPA and change controls to apply risk based methodology to validation efforts.
• Supported and maintaining Quality Assurance programs, policies, procedures and controls ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements and guidelines.

Confidential, Concord, CA

Lead Verification and Validation Engineer

Responsibilities:

• Led verification and validation activities providing hands-on leadership across Confidential medical devices system development process for Liberty Automated Peritoneal Dialysis and Hemodialysis Delivery Systems.
• Defined and developed V&V strategy for integrated medical device systems with Electro-Mechanical, Fluidics, Optics, Electronics, Embedded Software and Disposables.
• Authored validation package that includes User Requirements, Functional Specification, Design Specification, Validation Plan, Risk Assessment, Risk Management Plan, Qualification Protocols (IQ/OQ/PQ), Data Migration Plan, Traceability Matrix, Validation Summary Report.
• Ensured V&V documentation compliance with FDA 21 CFR Part 820, 21 CFR Part 11, EU Annex 11, IEC 62304 Medical Device Software Lifecycle, ISO 14971 Risk Management, Medical Device Directive 93/42/EEC, IEC 60601 Medical Electrical Equipment.
• Provided quality and compliance oversight for computer system validation and electronic records/electronic signatures compliance programs and performing 21 C FR Part 11 and Annex 11 assessments (gap analyses) to assist business areas and IT developing corrective action plans.
• Performed as a lead on implementation and validation of MasterControl QMS ensuring implementation plans, CSV, UAT to complete and qualify a system within given constraint of scope, time and schedule.
• Gathered and validated business needs to translate into business requirements to document Business Requirement Document (BRD) and transform the same into System Requirement Specification (SRS) and Functional Requirement Specification (FRS).
• Coordinated Verification and Validation, Unit Testing, Code Walkthrough, Functional Black Box/White Box testing, Intended Use/System testing) to ensure that system is validated.
• Contributed to SCRG (Software Change Review Group) and SPG (Software Planning Group) meetings to review defect fixes/proposed changes, implementation schedule and deliverables.
• Coordinated planning and implementation of corrective actions and preventive actions (CAPA) for software and instrument nonconformities.

Confidential, Foster City, CA

Lead Validation Specialist

Responsibilities:

• Validation of GxP computerized systems (21 CFR Part 11, Eudralex Anex 11, GAMP 5, SOX, PIC/S, HIPAA, SOPs guidelines) performing testing and validation of multiple applications and systems: MasterControl, InSight 4.7 to InSight 5.1 upgrade, LMS ComplianceWire, Argus 7, EDMS (FirstDoc and Documentum), Oracle 11.2.0.3 (Data Migration).
• Led cross functional teams of SMEs to complete detailed assessment of new or revised regulations and applicable standards initiating appropriate changes to External Requirements Plans for all company product families and coordinating with SMEs when additional testing or data is necessary.
• Analyzed business needs to be solved with IT systems and processes used in a GxP environment collaborating with business, quality, and technical individuals to ensure that applications and systems are in compliance with regulatory requirements.
• Created, analyzed and updated PRD, BRD, SRS, and Test Plans, project metrics, testing procedures with Engineering, Product, Operations, Finance, Sales and Marketing teams.
• Used risk-based approach to validation to determine the scope of validation for GxP systems to develop documentation and verification activities with appropriate justification of the approach.
• Provided quality and compliance oversight for computer system validation and electronic records/electronic signatures compliance programs and performing 21 C FR Part 11 and Annex 11 assessments (gap analyses) to assist business areas and IT developing corrective action plans.
• Participated and guiding the team in preparation of the validation package that includes User Requirements, Functional Specification, Design Specification, Validation Plan, Risk Assessment, Risk Management Plan, Installation, Operational and Performance Qualification (IQ/OQ/PQ) Protocols, Data Migration Plan, Validation Traceability Matrix, Validation Report.
• Performed validation of data migration on Oracle 11.2.0.3 on Source DB, Target DB and Staging Area. Migration qualification includes set up, pre-migration activities, execution of migration code, collection of migration logs, direct data mapping.

Confidential

QA Validation Lead

Responsibilities:

• Led validation of EMC Documentum D2, setting up enterprise standards for development and validation of Enterprise Level Documents and Content Management Solutions. Full life cycle implementation - from Blueprinting to Go Live and Support.
• Led validation of EMC Documentum D2, setting up enterprise standards for development and validation of Enterprise Level Documents and Content Management Solutions. Full life cycle implementation - from Blueprinting to Go Live and Support.
• Determined the scope of validation that included Content Migration, SAP Integration, Auditing, Reporting, E-Signature, Scanning to D2, Auto:Naming, Numbering, Linking, Virtual Documents, Relationships, Renditions, Dictionaries, Taxonomies, Templates.
• Tested the migration of the legacy systems documents and metadata (FileNet, SharePoint
• Tested integration of Documentum D2 to SAP Work Management (WM) module that enables enterprises to manage document and data connectivity, and associated regulatory compliance processes within the context of SAP application objects.
• Performed integration testing of Documentum D2/Enterprise Integration (EI) web services built on SOA Architecture using SoapUI 4.6.0 tool to validate web services that utilize standards like XML, WSDL, SOAP and Java Message Service.
• Modified end points, working on different servers (Oracle WebLogic, Apache Tomcat) and different versions of web services.
• Validated the process of Lifecycle Management workflows for automatically promoting files in workflow tasks (Review/Approval, Version Management, Change Control) to the next state in the lifecycle.

Confidential, Palo Alto CA

Sr. Quality Compliance / Validation Engineer

Responsibilities:

• Led Validation activities for implementation of a new TrackWise 8 system for Global Manufacturing & Supplier Quality Auditing (MSQA), Global Regulatory Compliance (GRC) Submission Planning Application Management.
• Validated custom TrackWise 8.0 CAPA system, track operational information, such as training, changes/change control, deviations, failure investigations, audits to facilitate efficient audit and retrieval of information, and to aid in trend analysis.
• Provided quality and compliance oversight for computer system validation and electronic records/electronic signatures compliance programs and performing 21 C FR Part 11 and Annex 11 assessments (gap analyses) to assist business areas and IT developing corrective action plans.
• Led validation of the upgrade of Documentum 6.5 to Documentum 6.7 with the impact on validating Business Process Management, Web Content Management, enterprise content classification, search and collaboration.
• Conducted software verification and validation activities on Saba LMS application hosted and delivered using a Software-as-a-Service (SaaS) model with an impact on Performance, Network Security, System Backup, Disaster Recovery, Data Integrity.
• Developed and executed investigational and instrumentation characterization protocols for various analytical test equipment, analyzing multivariate results, and preparing summary reports.
• Utilized FDA CFR Part 11 Gap assessments developing and executing CSV remediation plans to assure that business process is improved and efficiency increased while creating GXP compliant computerized systems.
• Participated in Change Control Board (CCB), reviewing proposed change control, assisting in the validation impact assessment regarding to the changes, generating testing to ensure and document that GxP systems are maintained in the validated state in production.
• Used risk-based approach to validation to determine the scope of validation for GxP systems to develop documentation and verification activities with appropriate justification of the approach.