SUMMARY

• Over 5 years of experience in FDA regulated Pharmaceutical environment with concentration in Technical writing, Equipment/Process/Cleaning Validation, and Computer System Validation
• Experience inValidationand testing of Medical devices, processes, and applications in FDA regulated Industry.
• Validation/QualityEngineerwith experience in using Risk Based Approach to validate Category 3, 4 tools and custom developed systems.
• Coordinate and execute processvalidationstudies, including IQ, OQ, PQ, TMVs, Gage R&R, and Equipment SoftwareValidationas required
• Understand, plan, and conduct Design of Experiments, Process Stability / Control / Capability methods, for process characterizations/equipment development, setting parameters.
• Develop process solutions by identifying, testing, and controlling factors that influence product performance and manufacturability
• Excellent experience in validating wide variety of applications and infrastructure - Medical Device Tools, Business Intelligence Reports, SAP, Excel spreadsheets, Electronic Document Management System (Documentum), Track Wise, LIMS
• Good expertise in developing the followingvalidationdeliverables - Risk Assessments, Regulatory Assessments, 21 CFR Part 11 Assessments, Gap Analysis documents,ValidationPlans, Qualification Protocols,Validationreports, IQ/OQ/PQ test scripts, Deviation/Incident Reports, Change Controls, and Problem Reports.
• Authored design inputs, functional requirements for legacy non-device software systems.
• Excellent knowledge of testing methodologies, strategies, and Software Development Life Cycle (SDLC).
• Involved in Change Control process and Periodic Review.
• Develop Test Plan, Test case Specification and Test Release Reports for all phases of testing i.e. unit testing, Integration testing IQ, OQ, PQ and UAT Testing.
• Experience in executing softwarevalidationprotocols (IQ, OQ and PQ).
• Demonstrated capabilities to quickly gain a detailed understanding of a process to optimize efficiencies, reduce cost, and improve quality.
• Excellent knowledge of 21 CFR Part 11/Part 820, ISO 13485, ISO 14971, GLP, cGMP and GAMP,CTQ guidelines.
• Worked on Software Development Life Cycle (SDLC) andValidationLife Cycle (VLC), familiar with Waterfall, Agile, and V-model.
• Excellent written, communication & interpersonal and Project Management skills.

TECHNICAL SKILLS

• 21 CFR Part 11/210/211- Quality System Regulation (QSR)
• 21 CFR Part 803- Risk Analysis
• 21 CFR Part 820- Process Validation
• GxP (GMP, GLP, GCP)- Cleaning Validation
• CAPA - Equipment Qualification (IQ/OQ/PPQ/PQ)
• GAMP- Computer System Validation (CSV)
• SOPs - Adverse Effect Reporting System (AERS)
• Documentum- System Development Life Cycle (SDLC)
• Share-Point- Electronic Data Management System (EDMS)
• Agile Model - Track-wise -Computer Systems Validation (CSV) GAMP5

PROFESSIONAL EXPERIENCE

Confidential, NJ

Process Validation Engineer/CSV

Responsibilities:

• Prepared documented procedures of the validation life cycle to ensure compliance with FDA regulations.
• Developed TMV protocols and reports for routine methods used in the laboratory.
• Validated computer systems using cGMP, cGLP and cGCP guidelines
• Documented and reviewed Standard Operating procedures (SOP's) for the various functions of the systems.
• Checked computer system validation (CSV) documentation and SOPs by leveraging best practices and software policies and procedures.
• Involved in development and execute Test Method Validations (TMVs), IMV develop, execute, review and approve Validation protocols (IQ, OQ, and PQ),SDLC and reports
• Provided gap analysis for the CSV Master Validation Plan of a facility-wide manufacturing control software upgrade installation.
• Provided insight and guidance to Quality and Regulatory Lead regarding CSV activities and deliverables
• Worked under FDA regulations and strictGAMPenvironment.
• Compliance review and assessment of current state ofvalidationsin preparation forFDAaudit.
• Involved in Developing theGxPEvaluation documents for module level and transaction level for the SAP application.
• Used US and International regulations including relevant parts of 21 CFR 820, 210, 211, 801, EN ISO 13485, and ISO 9001.
• Functional and Design Specifications were developed for lab equipment.
• 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.
• Reviewed templates for validation procedures of IQ's, OQ's and PQ's.
• Project Installation Qualification (IQ), Performance Qualification (PQ), Tooling Fixture Installation Qualification (TFIQ), Enterprise Change Request (ECR), and Design of Experiments, First Article Inspection (FAI),Critical to process(CTQ) .
• Development of all applicable documents for CSV (Computer System Validation) remediation per standards.
• Validationdocumentation author/review during theSDLC.
• Participate in the development and execution of CSV Life Cycle documentation.
• Created the Integration Test cases from Business Scenario's across all the modules for GxP impacted processes.
• Develop Equipment and Process deliverables such as IOQ, PPQ, CQ, and PQ.
• Facilitate Annual Risk Review and Risk Benefit Analysis, update Risk Assessment and Control Table, DHF, and Change Control documentation.
• Oversaw and led the execution ofvalidationprotocols, investigated and resolved deviations, Non-Conformances (NC) during execution of protocols
• Prepared list of documents required for the cleaning validation system based on GAMP5

Environments: Windows 7, Office 2010,Trackwise, SharePoint Server 07, CPDM- Document Manager, Mirage Project Scheduler, cGMP’s, cGDP’s, PPQ, Process Validation, Cleaning Validation, SVV Log (Bug Tracking & Test Execution Tool), (TSP) Team Software Process methodology, Rational ClearQuest, GXP,FDA CFR21; Parts 11, 820.

Confidential - Durham, NC

Computer System Validation

Responsibilities:

• DevelopedValidationProtocol Template forComputerSystemvalidation.
• Analyzing, coordinating and planning data/records as related to APQP and PPAP.
• Created the Design History Files (DHF) and updated them as per the changes made in the due course of design and development of Devices and Equipment.
• Oversaw all aspects ofcomputersystemvalidationincluding planning and developingvalidation approach.
• Reviewed, wrote and ledvalidation(IQ/OQ/PQ/PPQ/TMV) and provided technical input to ensurevalidationreports were qualified to company and regulatory requirement.
• Development of process quality plans, operations related plans and inspection standards for medical devices (FDA Class I/II) in collaboration with suppliers and in-line parametric QC tests and IQC methodologies.
• Writing Test Method Validation protocols for dialysis equipment.
• Writing, executing, reviewing Validation protocols like IQ, OQ, PQ for Computer System Validation (CSV), developing Standard Operating Procedures (SOPs) and Work Instruction (WI).
• Ensured that GxP regulatedcomputersystems were in full compliance with federal regulations and company policies and standard operating procedures.
• Participate in supplier visits, internal and supplier audits with conducting on-site supplier PPAP programs.
• Design, draft and prepare CSV system documentation and test documentation.
• Explained cross functional group in conducting analysis of NCMR's/ NCR's, with the purpose of evaluating the underlying issues and offering long-term solutions.
• Reviewed, identified and remediated legacy CAPA's for proper content (containment, problem investigation, risk assessment, GDP, root cause, action plans, etc.).
• Determined if the event required an MDR/MDV report that needed to be submitted to the FDA and/or other applicable Competent Authorities.
• Perform design of experiments (DOE), process engineering and process characterizations for the manufacture of class II medical devices.Conduct review of manufacturing, quality control, and packaging specifications as part of complaint investigation to ensure products were manufactured according to specifications.
• Supported supplier quality management programs such as supplier selection.
• Worked with Product Surveillance professionals in the areas of adverse event management, global reporting, trending, and led CAPA's

Environment: cGMP’s, cGDP’s, PPQ, Process Validation, Cleaning Validation, Quick Test Pro 9.5, IIS, Unix 2001, MS SQL, Oracle, TOAD, VB Script, Windows XP, MS Office,GXP, Microsoft Front Page.PLM tool

Confidential Malvern, PA

Responsibilities:

• Reviewed existing Standard Operating Procedures (SOP’s) for System Administration.
• Change control Procedure and Testing SOP’s.
• Gathered User Requirements from Business process owners.
• Reviewed URS (User Requirements Specification).
• Ensured process and product quality during the processing steps of solid dosage manufacture, such as weighing, granulation, coating, drying, compression, and encapsulation.
• Reviewed FRS (Functional Requirements Specification) document and DS (Design Specification) documents.
• Analyzed and reviewed validation deliverables like Validation Plan, Risk Assessment, Quality Assurance review, Validation Summary Report in compliance with GxP FDA Compliance Regulations.
• Was involved in reviewing Corrective Action and Preventive Action (CAPA) documentation.
• Validated the Integration of the CAPA Workflow with the other business workflows and the interfaces for the TrackWise workflow.
• Developed Test Cases for Functional and Regression Testing.
• Took part in weekly status meetings with Project leads, team leads and subject matter experts to update work progress.
• Worked with MS Visio to create workflow models and process flow models after reviewing URS and FRS.

Environment: HP ALM/Quality Center, MVS, SQL, PL/SQL, SQL Server, Teradata, SOAP UI, XML, QTP/UFT, Web services, Oracle, Data QualityAnalyst, PL/SQL, TOAD 8.0, SQL, UNIX.