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

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, Middlesex, NJ

CSV Engineer

Responsibilities:

• Preparation of Multiple cGMP Documents such as Commissioning, Validation, Qualification Protocols, SOP, Forms, Vendor Checklists, etc and also document quality issues and quality performance.
• Prepare, Review and execute Facility Qualification protocols including equipment’s that have been built and installed in compliance with their design specifications and as per OSHA Regulation.
• Prepared and execute cleaning validation protocol to clean a system or a piece of equipment using method such as Swab Sampling and Rinse Sampling.
• Experience in Validation of Electronic Document Management System (EDMS), SAP, Oracle Applications, Documentum, Trackwise, Argus Safety Management, Laboratory Management System (LIMS), Network and Infra Structure qualification in accordance with 21 CFR Part 11 and company standards
• Monitor the temperature and humidity for the pharmaceutical plant on daily basis.
• Prepared and Executed Installation, Operational, Performance Protocols (IQ/OQ/PQ) in compliance with FDA Regulations. Equipment’s include DI Water System, Blender, Drum Lifter, Metal De-Duster and Check-Weigher, Serialization, Aggregation, Capsule Filler, Fette Tablet Press, Mixers, Stability Chambers, Fermenters, Bio-Reactors, Packaging Equipment’s such as Capper, Sealer, Topserter, Labeler, Cotton Insertor, Cartoner, Blister Machine. Etc. Conducted Validation Deviation during Validation and found the root cause of failure using tools such as Cause and Effect and 5 Why’s after proper investigation and defined a Corrective and/or Preventative Actions (CAPA) for the same. Worked closely with the investigation teams.
• Outstanding experience in using HP Quality Center/HPALM (Requirements, Test Lab, Test Plan, Defects & Dashboard modules) for managing requirements, testing and defects.
• Specialization includes developing Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) as part of validation of various applications
• Expertise in developing Validation Plan, Validation Summary Reports and Traceability Matrix
• Excellent knowledge of testing methodologies, strategies and Software Development Life Cycle (SDLC) methodology
• Working on multiple projects which includes Creating, Populating, Budgeting, Scheduling, Maintaining Database using tools such as Microsoft Project and Procal. Developed a Method to support the Calibration and Preventive Maintenance Program, including review and approval of new and completed Calibrations and Preventive Maintenance (PM), review out of tolerances and support investigations evaluating product impact.
• 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.

Confidential, Eatontown, NJ

CSV Engineer

Responsibilities:

• Reviewed User Requirement Specifications (URS) and Functional Requirement Specifications (FRS) documents and prepared the Validation Protocols (IQ/OQ/ PQ).
• Initiated an innovation framework for packaging development, establishing new relations with third party design agencies and driving new packaging material sourcing.
• Performed and coordinated supplier audits as it pertains to R&D supplier selection process including supplier part and process qualifications and validations.
• Well versed in 21 CFR 820, 210 and 211, ISO 13485 requirements for Medical Device, combination and pharmaceutical products for agencies such as CDER, CDRH and MDD.
• Processed Medical Device complaints, risk assessments, conducted investigations, performed impact analysis, CAPA measures, root cause analysis and determination, and produced initial and follow-up Med Watch reports.
• Knowledge in implementing compliant and efficient Quality Systems to ISO 9001, FDA 21 CFR 820 for Medical Device developers .
• Used MS Visio for documenting work flow of project, MS Project for designing and programming the project activities.
• Work with Product and Process Engineer to transfer product from R&D to production
• Developed and involved in maintaining the Requirement Traceability Matrix (RTM) document to map the test steps with the User and Functional Requirements.
• Responsible for preparing, reviewing and executing Commissioning documents, IQ/OQ's for equipment validation protocols. Performed Smoke testing and user acceptance testing to the check the various functionalities of COTS.
• In-depth knowledge of GMP, GDP in regulated environments.
• Developed Detailed Risk Assessment documentation for managing the risk levels used before validation the system
• Providing Medical Device Quality Assurance technical expertise by participating in the day-to-day operation of the Department as it relates to the design .

Confidential

CSV Engineer

Responsibilities:

• Perform risk analysis and establish pFMEA for process validation.
• Perform GAP Analysis and develop Risk Mitigation Strategy.
• 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).
• Well experienced in validating Labware LIMS & SQL*LIMS
• Expertise in preparing Computer System Validation Plan (CSVP).
• Expertise in computer systems validation, System Development Life Cycle (Waterfall/Spiral), Validation Life Cycle, Testing methodologies, Deployment, SOP’s, Good testing practices and Good documentation practices.
• Experience in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA rules and regulations.
• 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.
• 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
• Controls for process and equipment validation.
• 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, 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.
• 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.
• Authored and reviewed Test Plans, Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ), Test Summary Report and Requirement Traceability Matrix (RTM).
• Performed various types of testing like Black box, White box, Performance and UAT testing.
• Performed other types of testing like load, stress, volume, integration, unit and functionality.
• Very proficient in writing Validation Summary Report (VSR) and Test Summary Report (TSR).
• Excellent verbal, documentation and organizational skills.
• Created and coordinated the execution, review and closure of multiple Change Controls for SAP.
• Perform Verification and Validation testing in an FDA/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