SUMMARY:

• Seven years of experience in Validation with strong background in Computer System Validation, Software Development Life Cycle, Technical Writing along with performing Manual and Automated Testing in the Pharmaceutical/medical industries including specialization in 21 CFR part 210,211,820 compliance and GAMP, GxP’s (GMP, GLP and GCP).
• Excellent experience in the validation of highly regulated enterprise level business systemsSiebel CRM, Laboratory Information Management System (LIMS), Clinical Trial Management System (CTMS),Adverse Event Reporting System (AERS), TrackWise, Inventory Management System and Remedy..
• Good working experience with LabWare LIMS software involving tracking raw materials and samples, modelling work flows, managing data collection and reporting and communicating this information to corporate systems, end users.
• 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.
• Experience in utilities and facilities qualification, equipment qualification, and computer validation.
• Experience with Factory Acceptance Test (FAT).
• Good understanding of 21 CFR Part 11, 210, 211, 820, GAMP 5 and associated FDA, GCP/ICH guidelines.
• Full validation life cycle experience including developing and maintaining SDLC for validated systems, Validation Plans, IQ/OQ/PQ/RTM, and validation reports.
• 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).
• Expertise in developing Test Strategies, Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and testing standards.
• Experience in using quality center to manage testing artifacts.
• Performed GAP analysis in identifying compliance gaps.
• Developed and 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 knowledge and experience in configuring and validating StarLIMS, SQL *LIMS
• Developed interfaces with laboratory instruments using StarLIMS Scripting Language
• Very proficient in writing Validation Summary Report (VSR) and Test Summary Report (TSR).
• Strong hands on experience in using Win Runner, Load Runner and Test director.
• Ability to work both independently and in a team-oriented working environment.

TECHNICAL SKILLS:

Tools: Quality Center, MS Office Suite Word, Excel, PowerPoint, Outlook, MS Visio, MS Project.

Operating System: Windows/Vista

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

FDA Regulations: 21CFR Part (cGMP’s),GAMP 5, 803 (Medical Device Reporting), 820 (Quality System Regulation).

Validation Deliverables: Validation Plan, Test Plan, Compliance Risk Profile, RTM, URS, FRS, OQ, PQ Protocols, Sop’s/Work instructions, System problem reports and System Certification Summary/Compliance Report.

Laboratory Equipments: Gas chromatography/Mass chromatography (GC/MS), Liquid chromatography(LS), Scanning Electron Microscope.

PROFESSIONAL EXPERIENCE:

Confidential, Memphis, TN

CSV Engineer

Responsibilities:

• Medical device analysis and remediation. Device History File: Product and Market Specifications. Test method validation, testing as per appropriate SOP.
• Statistics Process Control to comply with International, Standard such as ISO 13485. Performed Process development, and packaging validation review per ISO 11607.
• Design controls: performed design of experiments, new product introduction process; FMEA’s, GR&R, specification development, generated ECO’s, and performed validation/ verification. Improve the Corporate Quality System in the area of Statistical Analysis application for DV&V and PV&V, Test Method Validation (MSA), Risk Management per ISO14971 including FMEA. Integration of process control into product development during product design.
• Performed cervical modeling on 50% adult male human head dummy to ensure passenger safety condition with reference to HIC (Head Injury Criterion).
• Generated ECR (Engineering Change Reports) as well as handling DFMEA to consistently monitor and improve engineering design process.
• Engineered the complex stress strain calculations to improve the product life and effectively utilized DFSS concept to manage the 4M's.
• Participated on cross functional teams to launch products, resolve issues, and support product improvements
• Quality Management Systems. Designed test fixtures using Solid works, developed test methods, and executed gage R&R methods.
• Performed assessment audits of systems creating gap analysis - comparing ISO 9001 QMS to ISO13485. Up-dated systems incorporating ISO13485 elements established DMR and DHF, upgraded change control (ECR/ECO) process. Wrote/rewrote procedures, inspection instructions.
• Provided validation and quality engineering support: Developed training on meaning and content of Installation, Operational, and Performance Qualification (IQ/OQ/PQ) procedures. Performed as R&D QE design/development engineering activities.
• Established and Maintained Device Master Records (DMR)/ Design History files (DHF) - Design Reviews, Validation/Verification, IQ/OQ/PQ documents and Change Control process. After verification testing reviewed the test results for accuracy and completeness
• Implemented process controls for product and process improvements. Supported Inspection, 1st Article, In-Process- BOM's-WIP, Tests and MRB. Created data collection methods and statistical process control (SPC), Cpk, parato, yield, and trending reporting.
• Wrote and revised SQP's, labeling review, and document review prior shipping. Protocol Writing and Execution: Wrote/executed Commissioning, IQ/OQ/PQ, & Process Validation protocols

Confidential, Framingham, MA

CSV Engineer

Responsibilities:

• Documented various validation deliverable of system life cycle as required by FDA regulations under 21CFR Part 11.
• Reviewing the User Requirement Specification (URS) and the Functional Requirement Specification (FRS) document and analyzing the causes leading to discrepancies and failure of the pre-executed OQ scripts.
• Created design verification protocols/reports and test method to ensure each claim has supporting evidence in the DHF.
• Involved in creating test bed to check the Installation and Operational Qualification (IQ/OQ) for the application.
• Performed the ERES assessment of the overall functionalities of Argus Safety and evaluated the functionalities with a risk assessment based on the impact to the three core criteria: patient safety, product quality and data integrity and defined the testing strategy.
• Integration and Application UAT testing of SAP Success factor using HP ALM
• Performed GAP Analysis for Non Compliancy Training requirements in IT
• Responsible for building the IT training Curriculum for TBS (IT) Organization which lead to non-compliance falling from 55% to 9%
• Reviewed number of SDLC deliverables including System Design Specifications, User and Functional Requirement Specifications, IQ/OQ/PQ, SOPs/Work Instructions and Validation Summary Reports
• Developed UAT Test Cases and assisted the users during ‘Dry Run’ of Test Cases using HPALM
• Participated in developing templates, SOPs and training material
• Interacted with developers and various members of team to discuss and resolve defects arose during the UAT (User Acceptance Testing)
• Assisted in the maintenance of the CAPA.
• Experience in Data Migration, Periodic Review, GAP Analysis, and Risk analysis, FMEA and Remediation Process.
• Implemented GxP (GMP, GCP, and GLP) and GAMP guidelines in the systems.
• Performed TMV’s for Visual Inspection dimensional measurements.
• Developed Operation Qualification (OQ) test scripts for TrackWise Change Management modules and CAPA system.
• Drafting the Requirement Traceability Matrix document to track the URS and FRS are fulfilled by executing the OQ and PQ scripts.
• Prepared detailed SOPs for IQ and PQ for validating Autoclaves and HPLC detailing more on Filter sterilization, saturated steam checks including vendor specifications.
• Authored Requirement Traceability Matrix (RTM)

Confidential, Franklin Lakes, NJ

CSV Engineeer

Responsibilities:

• Followed Computer Systems Validation (CSV) Master Plan to author, review and approve CSV deliverables for systems as per GxP (GLP, GCP, and GMP) FDA Assessment.
• Profound knowledge in pharmaceutical/medical device regulations like FDA 21 CFR Part 11, FDA 21 CFR part 820 and ISO 13485.
• Involved in the creation of Validation Plan, Verification Protocols and Verification Summary report documents.
• Acted as HP ALM admin and was responsible for uploading requirements into HP ALM.
• Equipment validation and Technical documentation as per FDA/ISO 13485 and GAMP regulations.
• Maintained CAPA procedure, initiated investigation of non-conformances through root cause analysis (RCA), evaluation of the effectiveness of CAPA process, and initiation of action as required improving effectiveness.
• Analyzed test scripts to be compliant with 21CFR Part 11 regulations, maintaining validation Electronic records and following relevant SOPs.
• Provided systems engineering input, including requirements development and risk Validation assessment, for Design history file (DHF) remediation and new product development (NPD)
• Perform risk management assessment on all new and existing products.
• Perform Functional Verification/Validation Testing as per the features of the product.
• Provided validation guidance to SAP functional teams to ensure compliance to the regulations like 21 CFR Part 11, GDP and GMP.
• Developed Validation Master Plan (VMP) in accordance with FDA compliance standards
• Developed IQ/OQ/PQ and MSA protocols by identifying inspection and test activities, special measuring and test equipment, appropriate statistical techniques, data collection methods, and sampling plans for establishing, controlling and verifying process stability/capability.
• Involved in preparing compliance report about existing status of the cGMP, GCP and GLP.
• Involved in reviewing Validation deliverables Validation Master Plan (VMP), Validation Summary Documents (VSD), Validation Summary Reports (VSR), Installation Qualification/ Operational Qualification/ Performance Qualification, and Requirements Traceability Matrix.
• Develop and execute verification tests for client systems (i.e. medical software)
• Reviewed validation (IQ/OQ/PQ/PPQ/TMV) and provided technical input to ensure validation reports were qualified to company and regulatory requirement.
• Involved in auditing the application for 21 CFR Part 11FDA 21 CFR part 820, IEC 60601-1, ISO 13485, and ISO 14971. Compliance related to Electronic Signatures and Electronic Records for Trackwise System.
• Experience in Data Migration, Periodic Review, Change Controls, and Change Reporting, GAP Analysis, and Risk analysis, CAPA, FMEA and Remediation Process.
• Performed Statistical analysis for the FMEA risk assessment and performed Fault Tree analysis.

Confidential, Kalamazoo, MI

CSV Engineer

Responsibilities:

• Performed Test validations procedures, for dialysis machinery. Generate and execute validation test protocols and testing's. Conducted CAPA, continuous improvement, audit, quality systems and assurance, etc.
• Interacted with supplier for failure analysis report for components such as Supplier Corrective Action report as part of NCR and CAPA system.
• Provided effective support in all the stages of engineering design change process and document control. UDI project to change renal product labels to meet GS1 standards using change control process
• Developed supplier production parts by utilizing GR&R, Process Quality Control using SPC, Test Method Validation (TMV), Process Validation (IQ/OQ/PQ), Process Capability study, and First Article Inspection.
• Working on Critical activities like labeling subsystem requirements update, Event Based Risk Review, Label content approval, Labelling verification Report, Instructions for Use study, Trace matrix update, RACT update & DHF index update etc.
• Documenting IQ, OQ and PQ test scripts for new functionality and modifying existing test scripts, execution and SOP development.
• Updating the Requirement Traceability Matrix (RTM) upon completion of Functional Verification and User Acceptance Test execution and mapping the RTM to the Functional Specification, Design Specification and User Requirement Specification
• Analyzing Test scripts and mapping it to the URS to check functionalities covered.
• Understanding the system and writing the test cases by keeping into account the Trace Matrix and the specifications outlined in the URS.
• Involved in performing the GAP Analysis, Root Cause Analysis of the system and develop Remediation Plan.
• Responsible for documentation of all aspects of the Computer System Validation Life Cycle deliverables in accordance with 21CFR Part11 and Good Laboratory Practices.
• Gather, organize, analyze, maintain and interpret data
• Excellent Coordination skills, Communication Skills and strong Technical Writing skills and a good team player.
• Involved in all the phases of Software Development Life Cycle (SDLC) methodologies throughout the project life cycle
• Responsible for managing documents in the corporate document management system
• Coordinated between various teams to insure consistency and accuracy across test plans, user manuals and training materials.
• Detailed & complex analyses & tests requirements, FRS, performed test cases for research, and development. Executed Validation data analysis, reports, and recommendations for changes and/or improvements. Created test methods and fixtures for destructive strength tests.
• Developed and executed protocols for package design, packaging processes validation and package shelf life testing. Write protocols, perform studies, and evaluate the protocol test results, in accordance with 21CFR part 1