SUMMARY

• Over 7 years of experience in computer system validation and equipment validation.
• Expert - level knowledge of regulatory expectations as they relate to GxP computer systems (e.g., 21 CFR Part 11) and industry trends (e.g., GAMP 5).
• Highly proficient with all the phases of SDLC (System Development Life Cycle) process, validation methodologies and concepts of qualification protocols (IQ/OQ/PQ).
• Expertise in documenting User Requirement Specification (URS), Functional Requirement Specifications (FRS) and RTM (Requirements Traceability Matrices).
• Worked closely with development teams to define System Design Specifications (SDS).
• Create and execute validation test scripts and document test results in accordance with standards.
• Experiencing in performing risk assessment using the GAP Analysis, and implementation of various COTS applications.
• Good knowledge of White box testing, Black box testing, regression testing, User Acceptance Testing (UAT), Retrospective validation and Data Migration.
• Working experience in computer system validation in compliance with FDA guidelines, including Laboratory Information Management System (LIMS), Adverse Event Reporting System (AERS), Electronic Document Management System (EDMS) and Change Control Management Systems (CCMS).
• FDA regulated environment with good understanding of cGxP (GLP, GMP, and GCP), GDP, GAMP 4, GAMP 5 and risk assessment.
• Writing Standard Operating procedures (SOP’s) and User Manuals.
• Provided feedback in continuing validation process improvement.
• Experiencing in Corrective and Preventive Actions (CAPA) and suggesting the remediation plans to mitigate the non-compliance.
• Expert in reviewing and approving validation documents in accordance with company policies and procedures.
• Good knowledge of 21 CFR Part 11,210,211 and 820.
• Analyze results from allotted test programs to assure accurate, complete documents and results.
• Ability to work independently as well as being a good team player.
• Strong ability to prioritize and plan competing assignments; able to frame approaches and timelines for project work.

TECHNICAL SKILLS

Validation: FDA regulations, 21 CFR Part 11, GxP environments (GLP, GMP, GCP, GDP, GAMP 4 and GAMP 5), Audit trails, IQ/OQ/PQ protocols, validation summary reports and VMP.

Office tools: MS word, MS excel MS power point, MS office and SharePoint

Analytical software: LIMS, AERS, CCMS and EDMS.

Operating Systems: UNIX, LINUX, and windows7/8.

Methodologies: Agile model, Waterfall model, V- model and Spiral model.

PROFESSIONAL EXPERIENCE

Confidential, Swift Water, PA

Validation Analyst

Responsibilities:

• Written Standard Operating Procedures (SOPs) for the 5 phases of the CSV life cycle, in accordance with 21 CFR Part 11 and GMP regulation.
• Provided inputs to ensure periodic maintenance of computer software/hardware that were evaluated for revalidation to be in compliance with written standards, procedure, policies and guidelines.
• Developed qualification protocols (Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)) to support validation testing.
• Involved in designing and writing training manual templates.
• Analyze test results and document issues in the system. Worked proactively with Programmers, Business Analysts and Project Managers to understand and solve issues.
• Responsible for recording traceability Matrices.
• Developed training documentation and was involved in training users on GMP guidelines, and 21 CFR Part 11.
• Writing and execution of test scripts, test cases based on requirements of the application.
• Developing quality policies and procedures as related to validation.
• Coordinated with the Quality Assurance department to ensure all test scripts were executed successfully in QA/Validation environment.
• Generated, tracked, and maintained change control procedures and change management as and when necessary.
• Involved in reviewing existing validated documentation and evaluated executed change controls, reported problems in order to determine if any actions are required such as upgrading and replacement.

Confidential, Rockaway, NJ

Validation Engineer

Responsibilities:

• Prepared various deliverables in support of Computer System Validation Lifecycle in accordance with FDA regulations including Validation Master Plan, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Developed Traceability Matrix to ensure all critical Requirements are tested in full within the Validation Test Scripts.
• Review proposed changes via Change Control to validated systems and identify the validation requirements necessary to maintain the system’s validated state.
• Composed training decks and delivered training courses for Business Users and consultants.
• Conducted test script walkthroughs to ensure testing coverage is adequate and test scenarios specify the correct expected results.
• Worked on multiple projects and resources for successful project execution.
• Participated by providing inputs for risk mitigation activities.
• Revised existing and developed new Standard Operating Procedures (SOPs) in support of the systems being validated.
• Developed deliverables in compliance with GMP guidelines for validating Temptrax system.
• Written/executed/reviewed IQ/OQ/PQ test scripts in order to Validate Temptrax.
• Involved in reviewing and documenting User and Functional Requirements specifications.

Confidential, New York, NY

Validation Analyst

Responsibilities:

• Worked on the validation of Lab Ware LIMS version 5 and performed testing on the application for data acquisition and data management.
• Responsible for writing test cases, and test scripts for the Lab Ware LIMS modules.
• Involved in preparing and updating IQ, OQ, and PQ test plans.
• Conducted periodic evaluation to demonstrate that LIMS system remained in a validated state in its life cycle.
• Developed Validation Summary Report (VSR) to summarize all validation activities.
• Reviewed complete validation documentation to ensure actual results match expected results and all deviations that occur during the validation process are resolved appropriately.
• Provided training to validate test associates based on Good Documentation Practices (GDP).
• Initiated and handled meetings with end-users to review and approve business process procedures (BPP), User and Functional Requirement specifications (URS & FRS).
• Ensured requirements are met by completing a requirement traceability matrix.
• Worked in conjunction with Quality Assurance teams and provided guidance from a documentation perspective to business users during UAT.
• Assured that all validation variables are in compliance with the applicable SDLC methodologies.
• Reviewed test scripts (IQ, OQ, PQ) and Standard Operating Procedures (SOPs) to be compliant with regulations
• Provided documentation support during internal/external audits and regulatory inspections.
• Drafted SOPs according to GMP and 21 CRF part 11 requirements.
• Performed and coordinated individual tasks related to Validation work assignments and communicating the status to project management and relevant teams with further follow ups.
• Involved in retiring regulated equipments which included creating the retirement plan for retiring the system and retirement summary report.

Confidential, New Haven, CT

Validation Analyst

Responsibilities:

• Developed various Validation deliverables pertaining to Design/Development and Qualification Phases.
• Developed several IQ and OPQ scripts, end ensured all the Business (User/Functional) requirements are met.
• Responsible for developing all validation documents, primarily Validation Plan, Qualification Protocols, and Summary Reports.
• Identified system bugs and gaps, and guided the testers to perform qualification of the systems in Validation and Production environments.
• Participated in weekly status meetings with Business and CSV lead of the system.