SUMMARY:

• Eight 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 Confidential, 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 Confidential, 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 Confidential 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

Waterfall, V: Model, Spiral, and Agile.

21CFR Part 210: 211 (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 Summary/Compliance Report.

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

PROFESSIONAL SUMMARY:

Confidential, Morrisville, NC

CSV Engineer

Responsibilities:

• Created and Modified Change control, Change Plan, Impact Analysis, RA Tracking records In the Track Wise Application.
• Performed design verification pertaining to device QMS ISO 13485, 14971 for risk management.
• Responsible for providing Software Quality Assurance (SQA) engineering support for all lifecycle phases of computerized systems that include MES, TRS and PDM.
• Performed ERES Assessment, developed Validation Master Plan (VMP) for the SAP implementations.
• Verification and Validation of new product design and evaluation of design changes in accordance with 21 CFR part 820.
• Performed Detailed Risk Assessment by Failure Mode Effects Analysis (FMEA) for managing the risk levels used before validating the system.
• Drafted standard operating procedures (SOPs), and supported QA audits of existing operating procedures to ensure the compliance with company current regulatory requirements.
• Involved in all activities in SDLC life cycle.
• Created and coordinated the execution, review and closure of multiple Change Controls for SAP.
• Perform Verification and Validation testing in an Confidential /UL regulated environment.
• Managed traceability between requirements, design elements, and test cases in HP ALM.
• Workflows implemented included complaints, CAPA and Change Control.
• Involved in defect development life cycle (HPQC) and assigned the created defects to developers. Once the defect is fixed, Retested the defect and it moved to the closed status.
• Updated the following validation deliverables for projects - Issues Log, Incident Reports, IQ Protocol/Report, OQ Protocol/Report and Trace Matrix

Confidential

CSV Engineer

Responsibilities:

• Perform cleanroom validation tests such as filter integrity testing, particle counts to control airborne contaminants both in clean rooms, clean zones and cleanroom hoods (laminar and non-laminar flow hoods) within positive and negative pressure differential environments
• Validating retrospective remediation project by performing Gap analysis and establish Corrective and Preventive Action Plan (CAPA).
• Remediate audit findings and observations given by the auditors for regulated Research and Development (R&D) applications
• Excellent understanding of Software Development Life Cycle (SDLC), Software Test Life Cycle (STLC) and Test Methodologies.
• Possesses key skills in Financial equation, Insurance Processing, Payment Processing, EMR, EHR, HIPPA Compliance, Compliance (GxP & 21 CFR Part 11,) Good clinical Practice, Audits trials and Life sciences, Healthcare, Clinical Data management, EDI transactions, Clinical trials and HL7.
• Expertise in writing detailed Validation plan, Test cases, Test plans, Summary reports and Traceability matrix.
• Defect Tracking and Defect Reporting using Quality Center.
• Proficient in testing of Mobile application, Client/Server, GUI-based and Web-based Application on different environment.
• Experience in developing Validation Plan, test scripts, test plans, summary reports and Traceability matrix.
• Experience in Manual, Sanity, ETL, Database, GUI, Functional, Non-functional, Integration, Regression, User acceptance, White box, Performance and System testing.
• Understanding the Client Requirements and functionality of the system.
• Prepare and Execution of test cases as per requirement/user story and involve in preparing the traceability matrix using TFS.
• Attending scrum ceremonies (grooming, sprint planning, retrospectives, daily stand-ups, etc.) in Agile methodology.
• Performing testing for Web based, GUI based, Tablet, iOS and Android application.
• Coordinate regular review meetings with various project team members to ensure that quality is being maintain throughout the software development life-cycle (SCRUM) using JIRA.
• Establish cause-and-effect relationships by performing Design of experiments (DOE) to determine the relationship between factors affecting a process and the output of that process.
• Prepare and review Test Plans, Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ, Performance Qualification - PQ), Test Summary Reports and Requirement Traceability Matrix (RTM).
• Involve actively in all stages of process validation - Process Design, Process Qualification, and Process verification.
• Review Deviations, Change Controls, Material Change Controls, Document Change
• Controls for process and equipment validation.
• Establish SOP's and Work Instructions to fulfill Confidential commitment and design more robust validation practices.
• Assist as SME during internal and Confidential audits related to on-going process validation.
• Work with cross-functional teams to support Product Development and Engineering operations.

Confidential, Menomonie, WI

CSV Engineer

Responsibilities:.

• Support cGMP program including: Risk Analysis, Change Control, and Standard Operating Procedure using QUMAS. Support Site Expansion and Renovation activities including Commissioning and Qualification for Facility, Utility and Equipment related systems.
• Performed Gap Analysis, documented and defined the gaps and wrote Remediation Plan to bring the system in compliance with Regulation and participated in preparing the implementation plan.
• Extensive experience on Test Method Validation (TMV) for attribute and variable and analytical test methods.
• Working with the validation team leader, created the customer specific Equipment Installation and Operational Qualification Protocol (IOQ) standardized template, along with the templates for the Process Operational Qualification Protocol (OQ) and the Performance Qualification Protocol (PQ), intended for Phase I, II, Clinical Trials and Phase III of the Pilot Program development process.
• Ensured adherence by staff to quality, regulatory and GxP standards.
• Performing Verification and Validations of current system and the future state, performed Gap analysis with HIPPA compliance.
• Execute queries in Oracle/Teradata and conducting statistical analysis of results.
• Preparing Defect Report and assigning the defects to developer and involve in Involved in System and Functional testing using RQM.
• Mitigated defects by 23% by developing metrics to determine inefficiencies and areas of improvement across systems.
• Used SQL to perform database testing and monitor backend processing of data.
• Handling the tasks of helping the organization staff in planning data sets for UAT.
• Mapping functional requirements with test cases and retesting the cases where defect has been raised.
• Involved in all phases of SDLC according to Company procedures, FDA Guidelines, GMP.
• Performed V & V for all approved product contacted areas and product/process materials used.
• Authored and Executed IOQ, OQ and PQ protocols for a variety of automated assembly systems and on-line inspection and test systems, inclusive of software and/or firmware/hardware and PLCs systems.
• Created documents such as PFMEA, MVP, TMV, IQ, OQ, PQ etc.
• Received Company correspondence expressing appreciation for contributions made.

Confidential, Chicago, IL

CSV Engineer

Responsibilities:

• Maintained Requirements Traceability Matrix (RTM) to track requirements
• Involved in reviewing Corrective Action and Preventive Action (CAPA) and drafting Remediation plans for the project management approval after GAP analysis.
• Loaded IQ, OP, PQ, TMV documents into PDM (Product Data Management) system, (a controlled document/data management system) for review and approval signatures.
• Created validation products including Validation Scripts, Toolkits, Documentation, and Services (21 CFR Part 11, GAMP 5, ICH Q8/Q9).
• Using a risk-based approach, provided guidance on System Development Life Cycle (SDLC) and Computer System Validation (CSV) requirements for the implementation of all computer systems in compliance with Ricon Pharma's Quality Management System and GxP regulations.
• Involved in all aspects of the computer systems validation lifecycle, to comply with Confidential regulations.
• Involved in Calibration and Validation of Laboratory Instruments TOC-Analyzers, UV Spectrophotometers, Water baths, Centrifuges, Densitometers, Plate Readers and Imagers.
• Was involved in gathering User Requirements, conducting Gap Analysis and preparing the Remediation plan.
• Hands on experience in cleaning validation of various commercial solid dosage form equipment.
• Was involved in monitoring the processes that governed various tests like Bowie Dick test, Steam Penetration Test involving different activities like Flow rate Precision, S/N ratio and temperature control parameters.
• Prepared detailed SOPs for IQ and PQ for validating Autoclaves and HPLC detailing more on Filter sterilization, saturated steam checks including vendor specifications.
• Authored and executed CSV IQ/OQ and PQ activities for Clean-In Place (CIP) systems throughout the facility and USP PLC/HMI automated RO purified water distribution system.
• Reviewed and identified gaps in TMV protocols and reports for remediation/revalidation.
• Documented all materials during the testing phase of the project.
• Created for the use of SDLC/UAT / Business Procedural documentation for the Reporting.
• Trained operators for best practices to improve energy conservation efforts in Autoclaves, Refrigerators, Freezers, and Ovens which resulted in reduction of utility bills, downtime and maintenance costs.
• Monitored the testing conducted by QA department and documented the Validation Summary Reports.