SUMMARY:

• 7 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

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 Certification Summary/Compliance Report.

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

PROFESSIONAL EXPERIENCE:

Confidential, Boston - MA

CSV Engineer

Responsibilities:

• Authored and executed validation protocols (IQ/OQ/PQ) for GMP manufacturing, testing and packaging of parenteral commercial drug and solid dosage forms.
• Analyzed the Business requirements and prepared the Validation Master Plan.
• Maintained 21 CFR Part 11 compliance for computer systems by conducting Risk Assessments, identifying compliance gaps, and developing Remediation Plans.
• Developed the Electronic Records and Electronic Signatures Assessment document by performing Part11 assessment to the components involved in maintenance of Electronic Records, Electronic Signatures and Audit Trails in accordance with 21CFRPart11 regulations.
• Developed the User Requirements Specifications (URS), Functional Specifications (FRS) and the Design Specifications document (DS).
• Reviewed and updated end to end validation documentation for TrackWise to ensure compliance with company policies and procedures.
• Ensured documentation meets quality standards, applicable regulatory compliance and company guidelines.
• Involved in the validation of EDMS, GxP Assessment database, Change Management System Developed, reviewed and approved the Installation Qualification, Operational Qualification and Performance Qualification test scripts to check if all the functional requirements are met.
• Responsible for building test cases, test procedures and test reports.
• Analyzed test results to ensure existing functionality performs as specified and recommended corrective actions.
• Performed black box testing, positive testing, negative testing, front end testing and regression testing.
• Tracked, Investigated and resolved Bugs and defects using HP ALM.
• Prepared Deviation Reports when the test criteria did not meet the acceptance criteria.
• Developed Requirements Traceability Matrix (RTM) to map the user requirements to the functional requirements, design specification and the IQ/OQ/PQ test script references.
• Developed, Modified and reviews SOPs, Operating Manuals, SWPs, and User guides.
• Developed Change Control forms by determining the Technical Impact, Business Impact and developed the Change Plan to be executed for the Change Controls.
• Developed the Validation Summary Report to provide a summary of the validation activities and executed deliverables.
• Validated analytical laboratory equipment's such as Microplate Reader, GC, HPLC, LC/MS, Densitometer, UV-Visible spectrometer, titrators in compliance with FDA regulations.
• Created, revised, and managed Laboratory Equipment documentation including User Requirements Standards, Design Qualifications, Trace Matrices, Configuration Specifications and calibration documentation requirements.
• Performed basic to advanced configurations in LIMS to meet user requirements

Confidential, Lake Forest - IL

CSV Engineer

Responsibilities:

• Provided supportive documentation for Clinical Data Management.
• Developed technical content for user manuals through input from hands-on experience and subject matter experts.
• Documented and reviewed validation plan, user/functional requirements and risk assessments for any revisions or changes to be made.
• Worked with Documentum for managing technical documentation of projects and Annual Product Review.
• Wrote test cases and applied the test case design concepts to complete the validation deliverables in different phases of the project for IQ, OQ and PQ.
• Developed traceability matrix mapping unit, test cases and test scripts of all the projects of warehouse.
• Conducted GAP analysis for reporting purposes and managed all the change control records.
• Provided impact assessment analysis for data migration process.
• Authored, reviewed and executed various IQs, OQs and PQs to validate the system to meet the user requirements and to be in compliance with 21 CFR part 11.
• Developed and update the Trace Matrix to track requirements to ensure compliance with FDA regulations and quality review.
• Developed PQ protocols for the method transfer by leveraging them with equipment validation PQ protocols.
• Authored and executed test scripts and report issues in timely manner.
• Completed ISO 14971, 21 CFR Part11, 21 CFR part210, and 21 CFR part211 compliance assessments of laboratory and manufacturing (quality and analytical testing processes).
• Developed requirements and configured specification documents for TrackWise
• Authored and implemented Validation Plan and SDLC deliverables for the TrackWise release and Cleaning Validation process.
• Provided Business Analysis, Gap Analysis and recurring Enhancement/Change Requests and conducted feasibility study for Performance Impact Analysis.
• Evaluated Business Requirements for enterprise business applications integration and reviewed existing documentation for current systems to create AS-IS and TO-BE processes for GAP analysis.
• Analyzed business requirements for current and future state processes and composed business requirements documents (BRD) as per the business requirements and process flow.
• Distilled requirements into Functional and Non-Functional, and created documents such as BRDs, FRDs and SRS.
• Extracted the Business Requirements from the Stakeholders keeping in mind their need for the application and documented them using Rational Requisite Pro.
• Administered and tracked stakeholder requested enhancements using requirement traceability matrix (RTM).
• Created Use cases based on the requirements and Business process diagrams for the as-is and the to-be process utilizing UML methodology.
• Performed Requirement Analysis and developed UML Use Cases and Activity Diagrams to better illustrate the requirements.
• Worked on maintaining compliance of Electronic Records and Electronic Signatures with 21 CFR Part 11 regulations.

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).
• Prepared and reviewed Validation Master Plan (VMP) and Validation Summary Report (VSR).
• Followed SDLC Methodologies and industry standard practices to Validate Computer Systems.
• Gathered business requirements from end users.
• Gathered and documented User Requirements Specifications (URS) for various systems.
• Gathered, analyzed and created Functional Requirements Specifications (FRS).
• Authored and Executed the Test Cases/Test Scripts and Performance Qualification (PQ) to make sure the instrument works as per the business requirements.
• Gathered, analyzed, evaluated, and documented workflows, processes, procedures, and user requirements for LIMS.
• Respond to QA audit findings in a timely manner once the IQ/OQ/PQ are review by the QA auditors.
• Created User Requirements Traceability Matrix as a part of PQ Document to ensure all the requirements are being tested.
• Generated reports for Electronic Signatures and Electronic records for the different software versions used for the instrument as a part of 21CFR part 11 regulation.
• Create Incident reports/Deviation reports and Non-Conformance reports in order to be compliant with GMP regulations.
• Assessed the vendor documents (IQ/OQ) during installation and drafted Vendor Pre-approval documents.
• Closely worked with clients and vendors to support implementation and resolve the product issues during installation and qualification.
• Authored Validation Summary Reports after the completion of qualification to include all the qualification
• Developed and maintained the Requirements Traceability Matrix (RTM) in support of Validation.
• Analyzed and reviewed validation deliverables like Validation Plan, Risk Assessment, Validation Summary Report in compliance with 21 CFR Part 11, GAMP 5 and GMP FDA Compliance Regulations.
• Performed DFMEA and PFMEA Analysis. Performed GAP Analysis of existing RM Plans and suggested Remediation activities. Created Design History Files.
• Remediate audit findings and observations given by the auditors for regulated Research and Development (R&D) applications
• 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.
• Establish SOP's and Work Instructions to fulfill FDA commitment and design more robust validation practices.
• Assist as SME during internal and FDA 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.
• Involved in all phases of SDLC according to Company procedures, FDA Guidelines, GMP.
• Worked closely with external suppliers and organizations to resolve issues and prevent recurrence and continuously improve product quality. Major Suppliers included are Evoqua Water System, Optel Vison System, Western Pest Services, Fette, Glatt etc.
• 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 accomplishment 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 FDA 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.