SUMMARY:

Quality - driven Validation Engineer with over 6 years of experience in Information Technology as a QA/ Compliance/ in validating Computer Systems applications including ERP systems, SAP, LIMS, JDE, JDA, WMS, Medical Devices, and Lab Instruments in regulated companies in accordance with 21 CFR Part 11, GxP and GMP regulations. Highly proficient with SDLC process, validation methodologies and concepts of qualification protocols (IQ/OQ/PQ). Experience in reviewing and writing Computer System Validation Master Plan (CSVMP), Validation Plan, URS, Validation Test Plan, detailed Test Cases Formulation, Test Report and involved in Functional, Regression, Integration, Performance and User Acceptance Testing.

SKILLS:

ERP, JD Edwards

JDA, SAP

Software Integration

Structured Software

Software Development

Systems Integration, Life Cycle, Software Development Life Cycle

SDLC, Software Architecture, Software Life Cycle, Software Development Environment

Warehouse Management System

LIMS

Change Control

Project Development

Test Plan

ISO, scm, networking

SOPS, Java, JDE

Microsoft Access, MS Access

MS SQL Server, SQL Server, Oracle, SQL, Enterprise Resource Planning

RDBMS, unix, ms office, Functional Testing

Inspections, Stress Testing

Test Cases

Test Plans

User Acceptance

Acceptance Testing

Validation Iq, Validation Protocols

Validation Testing

GMP, QA, quality assurance, Quality Engineer

Test Scripts, Testing Tools, Automated Testing Tools,Automated Testing, Software Testing

CGMP, IQ/OQ/PQ, WMS, supply chain, Supply Chain Management, Inventory

FDA, GCP, GLP

Medical Devices,Quicktest, Regression Testing, System Validation, User Acceptance Testing

Integrator, Integration, Architecture, GXP, Risk Assessment, LMS, Design/Build, RTM, Validation Engineer

Documentation, Software Requirements

EXPERIENCE:

Confidential

CSV Specialist

Responsibilities:

• Ensured documentation and practices to meet quality standards, applicable company's policies and procedures
• Performed risk assessment in support of computer system validation
• Developed validation documents such as IOQ, user requirements, functional specifications, validation plans, test plans, traceability matrix, deviations and summary reports
• Assisted in developing computer system validation deliverables for FDA - regulated applications: validation plans, required specifications, various levels of software testing scripts (IQ, OQ, PQ), traceability matrix and risk assessment and validation reports.
• Review the accuracy and completeness of software validations deliverables
• Working knowledge of GxP systems and related regulations and guidance, e.g. 21 CFR Part 11, GAMP 5

Confidential, Parsippany, NJ

CSV Quality Engineer

Responsibilities:

• Provided and supported technical and procedural expertise/guidance to project teams as well as aligning with both internal and external stakeholders for Confidential, Infrastructure, Computerized System Validation (CSV) and Quality Management System (QMS).
• Supported and responsible for writing/approving of validation documentation deliverables including the approval to release system/infrastructure implementation and/or changes for production use, attended Project Team meetings and provided compliance guidance and support to project.
• Build and maintained trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helped others to do the same.
• Proactively monitors processes to ensure compliance with standard operating procedures and industry best practices.
• Follows - up on portfolio of validation projects and helped resolution of key issues and escalations keeping management informed of trends, recurring issues and work with teams to resolved issues.
• Assisted with authoring and approving of validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans, URS, Test Plan, IQ, OQ, PQ's and Reports.
• Worked with large scale end-to-end Validation programs like JDA, JDE ERP, LIMS, CAPA, SAP, LMS.
• Executed and Validated Warehouse Management System (WMS) modules
• Working knowledge of SDLC, GAMP 5, and thorough knowledge of cGMP, GCP and GLP regulations related to CSV, including 21 CFR Part 11, and Annex 11.

Environment: ERP, SAP, JD Edwards, GMP, GxP, 21 CFR Part 11

Confidential

Computer System Validation Analyst

Responsibilities:

• Supported implementation of a custom developed WMS on the SAP platform as a part of operational and warehouse consolidation Assure compliance of computer software solutions, in conjunction with various regulatory standards and internal quality assurance processes and CSVMP.
• Prepared, reviewed, executed, and summarized validation protocols (IQ, OQ and PQ protocols) Change Requests, SOPs for LIMS and ERP
• Performed Verification and validation analysis of systems and software architecture, and software requirements, design, software interfaces, software integration and the systems integration test products.
• Served as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention
• Provided validation support for the review and design of new systems and modifications to existing systems to ensure designs comply with current validation standards and are able to be adequately validated and maintained within validated control
• Performed validation testing for new products, process improvements Interact with individuals from different disciplines (Manufacturing, Quality Assurance, Engineering, and Operations) to plan, execute, and complete validation protocol
• Maintained procedures to regulate change implementation (Change Control Procedures) to ensure system compliance through its life cycle.
• Ensure validation efforts are conducted in an appropriate and timely manner
• Perform and lead risk assessment exercises in support of validation activities
• Prepare Technical Packages and assessments for product transfers
• Act as back up to Validation peers as needed Ensured computer and IT systems validation meet internal and external regulatory requirements such as FDA, GMP, cGMP, etc.
• Support Regulatory inspections, internal and partner audits, and implement corrective actions as needed.
• Provide computer system validation related responses to inspectors/auditors.

Environment: Metis (ERP), SAP, LIMS, CAPA, GMP, GxP, 21 CFR Part 11

Confidential

Computer System Validation Analyst

Responsibilities:

• Co - ordinate resources required to complete validation qualifications and tests in a timely manner Provided validation support for the review and design of new systems and modifications to existing systems to ensure designs comply with current verification & validation standards and are able to be adequately validated and maintained within validated control
• Lead the efforts to complete assigned validation protocols
• Monitored quality review and approval of computer and IT systems validation documents to ensure that the documents are accurate, complete, and meet internal and external regulatory requirements such as GMP, ISO, GAMP, etc.
• Coordinated validation deliverables with the business, IT and other quality representatives to maintain and promote validated application environments.
• This includes development and establishment of quality assurance measures and testing standards for new applications, products, and/or enhancements to existing application throughout their development, product lifecycles.
• Reviewed and approved integration and acceptance testing of new application Projects along with regression testing of changes to existing applications.
• Review and approved written and manually executed test scripts to support technical projects, regulatory submissions and coordinate the validation activities to meet critical project deadlines and and/or launch dates.
• Developed and executed validation IQ/OQ/PQ protocols as part of a Validation Master Plan, Change Requests and SOPs.
• Executed and Validated Warehouse Management System (WMS), Supply Chain Management System (SCM) and Inventory Management System modules
• Resolved qualification deviation
• Experienced in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP for FDA approval.

Environment: ERP, LIMS, FDA, GMP, GxP, 21 CFR Part 11

Confidential

Computer Systems Validation Engineer

Responsibilities:

• Developed and executed CSV deliverables according to regulatory authorities for GxP computer systems to support commercial and development activities
• Developed Validation Assessments, Project Validation Plans, (IQ) Installation Qualification Protocols, (OQ) Operational Qualification Protocols, (PQ) Performance Qualification Protocols, and Traceability Matrices for new applications.
• Provided training to Jr. Validation consultant to execute protocols, guide the execution of validated activities, and work closely with QA department to close out executed protocols
• Developed Standard Operating Procedures that support Computer Systems Validation
• Assessed pre - existing GxP computer systems for compliance gaps and recommend solutions
• Coordinated and performed all CSV Provided guidance for CSV activities performed by contract service providers
• Assessed change controls for impact to validated computer systems
• Participated in cross-functional Project teams to ensure business needs are met and implemented in compliance with associated predicate rules and governing regulations.
• Pro-actively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices.
• Builds and maintains trust, collaborative relationships and partnerships with internal stakeholders which help accomplish key business objectives

Environment: Quality Center, Oracle, SQL GMP, GxP, FDA