SUMMARY

• Over 8 years of experience as a High skilled Technical Writer professional with a demonstrated record of achievement working on GxP (GCP, GLP, GMP) computer systems.
• Excellent Knowledge and experience in Good Documentation Practices.
• Knowledge of ISPE’s GAMP, GAMP4 & GAMP5 guidelines to validate GAMP categorized software’s.
• Proficient in Performing Validations including Prospective and Retrospective, Computer System, Instrument/Equipment,
• Well versed in phases of clinical trials and GCP as of 21 CFR 50 and 56.
• Excellent experience in applying FDA regulations to the aspects of the Computer and Lab Systems.
• Experience with Laboratory equipment like Particle counters, HPLC, GC, UV - Vis Spectrophotometer, Balances, Centrifuges, Thawing devices, pH meter.
• Experience in validating Veeva Vault QMS and Clinical Suite, SAP ECC 6.0, Oracle EBS, LIMS, Lab Instruments, Lab Interfaces with ERP systems.
• Experience in reviewing all SDLC documents, protocols and SOP's to ensure they meet GxP and FDA regulations
• Proficient in using HP ALM and Quality Center for creating, executing, reviewing and approving requirements, test scripts, test runs, and defects.
• Excellent analytical, problem solving, communication and interpersonal skills with good work ethics and ability to interact with individuals at all levels of the organization.
• Good experience with MS Visio in developing Workflows, flow charts and flow diagrams.
• Lead Computer System Validation in compliance with 21 CFR Part 11 and GxP FDA Regulations and QSR 820
• Hands on experience on HP ALM (Requirements, Test Plan, Test Lab and Defects modules).
• Experience in validation of various IT systems Oracle EBS (Advanced Supply Chain Planning, Quality, Accounts Receivebales, General Ledger, BOMS, Routings, WMS, Procure to Pay), LIMS (Laboratory Information Management System), Track Wise (CAPA, Complaints)
• Demonstrated capability to quickly gain a detailed understanding of a process in order to optimize efficiencies and improve quality.
• Abundant experience in generating and reviewing Computer Systems Validations CSV Deliverables according to 21 CFR Part 11 and FDA regulations for the Pharmaceutical industries
• Experience in System Retirement activities according software development life cycle.
• Experience in all phases of the software development methodologies such as Waterfall, V-Model and Agile etc.,
• Experience in UDI validation.
• Working knowledge of GLP, GCP, GMP, GAMP 5 guidelines especially in the areas of computer or related systems
• Experience in preparation and review of Validation Protocols IQ/OQ/PQ documentation, VP, VSR, SOPs, Protocol Deviation, Risk Assessment, Decommission report, Periodic Review Report.
• Experience in Developing and reviewing User Requirement Specifications URS, Functional Requirements Specification FRS and Requirement Traceability Matrix RTM Documents
• Good experience in Gap Analysis and documenting Remediation Plan
• Experience as a Technical Writer to establish Standard Operating Procedures (SOPs), Work Instructions, and User Guides

TECHNICAL SKILLS

Testing tools: HP ALM, Quality Center, JIRA X-ray

Validation Deliverables: Validation Plan, Test Plan, System Criticality Assessment, RTM, URS, FRS, IQ, OQ, PQ Protocols, SOP’s/Work Instructions, Data Migration Plan, Data Migration Report, Test Defect reports, Test Reports, Validation Reports

Methodologies: Waterfall, V-Model, Agile

Operating System: Windows 2000/2003/XP/Vista/7

Tools: MS Office Suite Word, Excel, PowerPoint, MS Visio, MS Project, Share Point.

PROFESSIONAL EXPERIENCE

Confidential, New Brunswick, NJ

Sr. Computer Validation Engineer

Responsibilities:

• Development and Execution of Computer System Validation (CSV) documentation according to cGxP guidance for Analytical Laboratory Test Equipment and other Lab Information Systems.
• Executed Computer system validation Data Integrity /Electronic Records Electronic Signatures (DI/ERES) and Unit Test Plan for each platform for GMP Lab systems of Biopharmaceutical Product Development and Supply (BPDS) for Cell Banking Manufacturing and Testing (CBMT), Microbiology, Systems and Analytical Services - Pilot Plant Support (MSAS - PPS) with Win 10 Upgrade.
• Responsible for Qualification, Calibration and Maintenance of HPLC, UPLC, GC, FT-IR, UV-Vis Spectrophotometer, Dissolution apparatus and other analytical instruments and utilities.
• Authored and executed Qualification and Re-Qualification protocols for the analytical Equipment such as HPLC, UPLC, GC, FTIR.
• Documentation include, but not limited to: Create and manage Risk Assessments, Validation Plans, Design Specifications, User Requirements, Functional Requirements, IQ/OQ/PQ Protocols, Requirements Traceability Matrices, Summary Reports, Exceptional condition and functional business process flows and risk assessments.
• Write risks assessments and applicable test scripts according to cGxP and 21 CFR Part 11 compliance guidelines and the Validation Master Plan.
• Development including Create, review and modify of SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documentation.
• Initiating decommissioning and leading change controls for implementation of new instrumentation, equipment and systems.
• Developing and executing validation protocols maintaining Data integrity and ALCOA principles.
• During execution Constant touch base with vendor for developing testing, validation and/or quality strategies.
• Work with project teams to select methods and techniques for obtaining desirable solutions for each project and work with QA to ensure compliance with regulation.
• Work collaboratively to ensure the development of CSV best practices.

Confidential, Boston, MA

Validation Engineer

Responsibilities:

• Responsible for leading Validation activities for Oracle EBS system (Application Version R11i Database 10g), TrackWise
• Validation Lead for the implementation of Veeva Vault Quality Suite and Oracle EBS Validated CAPA, Complaints, NC and Audit modules in Veeva Vault’s QMS.
• Implemented Author, Review, Approve, Issue, Supersede and Obsolete document lifecycle phases in Veeva Vault’s QualityDocs module.
• Lead Data Migration activities from Legacy System to Oracle ERP system
• Coordinated with Business in creating Future Business Process Design documents for WMS, ASCP, GL, AR, Costing, Quality Process areas
• Participated in the analysis of the User Requirements and Functional Requirements for Oracle EBS, Agile PLM and LIMS.
• Created Process Flow documents for CAPA and Complaints modules in TrackWise
• Reviewed and approved Functional Specifications and Technical Specifications for the interfaces developed between CDS Systems, LIMS and EBS.
• Conducted Risk Assessment sessions to analyze the GxP, Business and functional impact on the user requirements with process owners, functional team and QA compliance for various ongoing projects and authored the Systems validation Risk Assessments.
• Trained testing personnel on HP ALM usage.
• Developed Business Requirements model, Validation Plan template, Traceability Matrix, Installation Qualification test scripts, Operation Qualification test scripts, Performance Qualification template, Validation Summary Report template with Argus
• Developed Test Report, Deployment Plan and Validation Summary Report to summarize the testing and validation efforts.
• Reviewed and approved Requirements in ALM
• Reviewed and approved UAT test scripts in Test Plan and Test lab modules of ALM before and after execution respectively.
• Reviewed and closed defects for the testing in ALM.
• Prepared Deviation Reports, Deviation Logs for the various errors occurred during the testing phase of SDLC.
• Prepared and executed validation protocols (IQ, OQ and PQ).
• Involved in all phases of SDLC for V-type, Waterfall and sprints for Agile methodologies
• Followed standard, measurable Gateway Exit process to ensure readiness of the team and for the project to proceed to next gateway check point.
• Developed SOPs for Formal testing and 21 CFR Part 11 Assessment.
• Updated existing Validation and Quality Management Systems SOP to reflect both project and system level documentation and Roles and Responsibilities.
• Developed/Maintained the Requirements Traceability Matrix (RTM).

Confidential, NJ

Validation Engineer

Responsibilities:

• Performed Validation Testing on the application in accordance with 21 CFR Part 11.
• Prepared, revised, and implement IQ, OQ, and PQ validation protocols and reports according to GMP guidelines, ensuring execution and documentation of the qualification process for the laboratory equipment to include GC, HPLC, UV-Visible spectrometer, TOC Analyzer, ICPMS, and dissolution.
• Supported lab operations team by preparing technical documents such as SOPs, qualification protocols, change controls, periodic reviews.
• Drafted and executed Qualification and Re-Qualification protocols for the analytical Equipment such as HPLC, GC, UV-Visible spectrometer, TOC Analyzer, ICPMS.
• Implemented and developed a standard process for using Electronic Signatures on all electronic-document transfers using the 21 CFR part 11 standards.
• Responsible for carrying out Validation activities for LIMS
• Used Documentum Application for reviewing and uploading the Validation documents.
• Ensured compliance with all applicable GxP regulations, policies and procedures related to Information Technology and computer systems
• Involved in all testing activities including IQ, OQ and PQ using HP Quality Center
• Responsible for ensuring the compliance of GAMP and FDA regulations.
• Maintained existing System & Integration Test Plan according to the Standard Operating Procedures (SOPs) and VSD.
• Involved in evaluating the 21CFR part 11 requirements and creating a check matrix for the same.
• Involved in User meetings, Design sessions to capture the System Requirements and documented in System Requirement Specification (SRS) including interface requirements with other systems.
• Developed and reviewed URS, FRS, Test Plan and Test Scripts.
• Prepared/Executed IQ, OQ, PQ/UAT Test Plans, Test Scripts and Test Summary Reports.
• Created Regulatory Assessments, Risk Assessments, 21 CFR Part 11 Assessments Reports.
• Developed/Maintained the Requirements Traceability Matrix (RTM).
• Maintained Training Logs and Incident/ Test Case Assignment logs.
• Coordinated with Business and Technical folks in developing a rationale for unresolved Defects.

Confidential, Newhaven, CT

Quality Engineer

Responsibilities:

• Developed Work Instructions, PM Plans, testing plans, protocols, Evaluation studies, Engineering Studies, auditing of CAPA. QM documentation auditing, complaint management, qualifications, auditing and process validations. Involved in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols from the supplier side.
• Created and executed TMV s for pull test and leak test.
• Used statistical techniques to measure, evaluate, and optimize raw components, assemblies, finished goods and operations processes (GR&R, SPC, Capability analysis, DOE, etc).
• Worked in a team with product development teams to establish testing plans and protocols for new and existing products as part of NPD activities.
• Managed Non - Conforming Material Reports (NCMRs), Corrective and Preventive Actions (CAPAs) and aid in complaint investigations from beginning to end.
• Worked with Remediation works under EU MDR, DHF Documentation, MDD in order to create and work accordingly on the project.
• Involved in Engineering change order Management with ECN, MCR and ECO as part of change requests with design, process, print, ERP status, specifications.
• Actively involved in Technical drawing standards and control charts, DHF, DMR validating and updating of the same along with the DHR activities and Device control documentation.
• Gathered and analyzed data for root cause analysis. Coordinated and drove efforts to assure CAPAs are opened and completed appropriately. Worked with Engineering and Manufacturing to develop and implement corrective actions under CAPA.
• Worked with change orders, change control, initiated, modified, updating of change orders, change authorization and related documentation.
• Coordinated efforts to design, develop and validate manufacturing processes using tools such as Design of Experiments (DOE), PPAP, Measurement System Analysis (MSA), Remediation activities, DFM-Design for Manufacturability, SPC, Failure Modes and Effects Analysis (FMEA), SCAR activities, Statistical Process Control (SPC), and capability analysis.
• Conducted Correlation and Regression Analysis, testing protocols, Experimental Design (DOE) and acceptance sampling; as well as conducting Gage R&R studies.
• Analyzed reports and specified corrective actions to products in order to have better and error free products.
• Extensively worked on Design history files, document change control and Design control records along with protocol documentation works.
• Involved in Design and Failure mode analysis (DFMEA) the products as mentioned and Class 2 medical devices.
• Was involved in development of CMM and related model developments to address capability.
• Applied statistical methods and process/design excellence tools to establish validation and test plans as well as evaluate test data and processes.
• Supported the manufacturing facilities by evaluating non-conformances and participating in NCBs to address issues.
• Worked extensively on statistical data along with the help of Minitab, sampling plans and observed the trends and deviations in the data.
• Identified and implemented GMP s (good manufacturing practices) that apply to specific production area(s) and providing training as needed to ensure production team understands and can complete assembly procedures while following GMP s.
• Involved in Root cause Analyses and integrating with corrective actions in order to make the process even more capable.
• Well versed with batch records, discrepancy management systems.
• Applied Six Sigma and Lean tools to solve production problems and improve existing processes.
• Responsible in Monitoring and managing of record keeping and retention of records DHF.
• Worked in control with the quality team with respect to assembly procedure word files. Supported risk assessment activities ISO 14971 through DFMEA, PFMEA and other QA risk analysis techniques to manage potential risk management during development and commercialization.
• Participated in product development teams to provide technical review of design input specifications and design documentation for new medical devices and identified and documented hazards and risk management aspects of the project.
• Identified workflow improvement opportunities while working cross functionally with operational and support teams
• Performed assessments to analyze the current state of operations, developed procedural changes, recommended and executed continuous improvements, and implemented necessary controls to sustain results implemented necessary controls to sustain results.

Confidential

Intern

Responsibilities:

• Assisted Validation Testing on the application in accordance with 21 CFR Part 11.
• Develop and execute Test scripts.
• Assisted in performing process qualification for new equipment and new technologies.
• Authored validation protocols and engineering studies.
• Developed Requirements Traceability Matrices.
• Developed Validation Summary Reports.