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Csv Engineer Resume

Morrisville, NC

SUMMARY

  • 6 years of experience in Pharmaceutical and Biotechnology industries within quality, regulatory and clinical environments as a Validation Analyst, Computer System Analyst Engineer specializing in Quality, Validations (Computer systems, Laboratory Instruments)
  • A validation professional having diversified experience in pharmaceutical, biotech and medical device industries as Computer System Validation (CSV) Analyst, Technical Writer and QA reviewer in FDA regulated Manufacturing and R&D departments.
  • In depth knowledge on FDA regulations 21 CFR Part 11(Electronic Records and Electronic Signatures, Audit Trails and Security events etc.), part 210, 211 (for pharmaceuticals), part 820 (for Medical Devices), ISO13485 (Medical Device - Quality Management System).
  • Strong QA knowledge, GMP, GAMP 5 and FDA Regulatory compliance knowledge.
  • Excellent experience in performing Risk Assessments - FRAs and FMEAs based on GAMP5 regulations.
  • Extensive experience in Software Development Life Cycle (SDLC), Information Technology Infrastructure Library (ITIL) processes and familiar with Waterfall Model, V- Model and Agile Methodologies.
  • Performed testing reviewing and executing the Test Scripts using HP QC.
  • Extensive experience in writing and reviewing Standard Operating Procedures (SOPs), Work Instructions (WIs), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), System Design Specifications (SDS), Requirement Traceability Matrix (RTM) and Validation Summary Report (VSR) etc.
  • Strong experience in writing and executing IQ/OQ/PQ protocols, protocol execution and test plans for Validation Testing.
  • Strong experience and knowledge on cGxP (GCP, GLP, GMP, GDP) in pharmaceutical industries.
  • Experience in writing and reviewing Computer System Validation Plans and Remediation Plans.
  • Strong experience in validating and handling of ERP applications like Serialization, Change Control Management System (CCMS), Laboratory Information Management System (LIMS), Manufacturing Execution System (MES), Enterprise Document Management System (EDMS),IRMS (Information Request Management System) Web - MI (Medical Information), AE (Adverse Events), PC (Product Compliant) and QA (Quality Assurance) modules, TrackWise, Oracle EBS r12.
  • Well versed in variety of Testing Methodologies and Automated tools in QA field.
  • Writing, Reviewing and approval of the Validation Protocol and Summary reports.
  • Experience in writing Risk Analysis, Gap Analysis, and CAPA documents.
  • Hands on experience in creating Corrective and Preventive Action Plan (CAPA) and performed the Gap analysis to remediate audit findings and observations given by the auditors.
  • Excellent knowledge and experience in Good Document Practices (GDP)
  • Specialized in automated testing using HP Quality Center.
  • Good experience in performing manual testing methods like Integration Testing, Black box Testing, Functional Testing, Regression Testing, Backend Testing.
  • Good experience in handling Non-Conformances, performing Gap analysis and preparing Remediation Plans.
  • Excellent interpersonal, organizational, verbal and written communication skills.
  • Extensive experience working with MS Visio, PowerPoint, Word and Excel.

TECHNICAL SKILLS

Computer System Validation: 21 CFR Part 11 (210/211, 820), GAMP, cGMP, GCP, GLP, IQ, OQ, PQ, RTM, SOPs, Summary Reports, Audit Trails, LIMS, SOX Guidelines, Trackwise, Share Point, ATLAS, eRoom, Argus safety, AERS.Oracle ERP systems

Testing Tools: HP- Quality Center, Quick Test Professional, Win Runner 6.x/7.x, Load Runner 6.x/7.x, HP ALM

Business Tools: MS Office (Word, Excel, Active directory, Power Point, Access, Visio), SAP, Documentum, SQL, Migration tools, Service NOW, Trackwise.

Operating Systems: Windows 2003/Vista/7/8/10,NT/XP, LINUX, MAC

PROFESSIONAL EXPERIENCE

Confidential, Morrisville, NC

CSV Engineer

Responsibilities:

  • Developed Validation Plans (VPs) for different clients implementing Serialization software.
  • Assisted in developing URS and FRS documents based on business needs.
  • Developed FMEA for the application functional requirements to assess the failure consequences and to determine the level of testing.
  • Developed, reviewed and updated Configuration Specification Documents for Serialization software.
  • Developed and Executed IOQ for the application (Verify Brand Software).
  • Performed Data Integrity Assessments (DIAs), Backup and Restore process for the clients implementing Serialization software’s. Performed verification of:
  • Access and Security; Audit Trials and Signatures; Data Integrity etc.
  • Performed Electronic Record Electronic Signature Assessments, User Access Reviews etc.
  • Generated EPCIS messages using Jennasson Serialization Test Tool.
  • Configured Jennasson Serialization Test Tool.
  • All deviations occurred during the execution of protocols were assessed with Business and resolved with any corrective actions.
  • Performed GAP Analysis for the execution.
  • Developed Traceability Matrix (TMX) to map requirements to testing.
  • Developed Validation Summary Reports (VSRs) to close the validation activities and then document the deviations from Validation Plan included open Action Items.
  • Participated in the Feature reviews of the Application.
  • Participated in the Product review with the Client.
  • Developed Change Controls for Hotfixes of the Application.
  • Developed IOQ Protocols for Azure Migration of the Data Centers.

Confidential, Rockville, MD

Validation Analyst

Responsibilities:

  • Developed Validation Plan (VP) for both the applications and assisted client in developing URS and FRS documents based on business needs.
  • Developed FRA for functional requirements to determine level of testing.
  • Developed IOQ and PQ for both the applications and then executed as per Thermo Fischer standards.
  • All deviations occurred during the execution of protocols were assessed with Business and resolved with any corrective actions.
  • Developed Traceability Matrix (TMX) to map requirements to testing.
  • Finally, developed VSR to close the validation activities and deviations from Validation Plan were documented.
  • Also assisted client to getting the change control tickets approved.

Confidential, NJ

CSV Analyst

Responsibilities:

  • Involved in the development of URS and Validation Plans for both IRMS and BI Reporting applications with the help of Business users and IT.
  • Assisted in developing DDS (Detailed Design Specification) documents, which include both Functional Specifications and Design Specifications for BI Reports.
  • Worked with Business and developed Functional Risk Assessment (FRA) for the vendor provided FS for IRMS project.
  • Developed Data Conversion and Migration Plan (DCMP) for the migration of ETL (Oracle Data Warehouse) for BI Reporting between DEV, QA and PROD environments.
  • Developed and executed IOQ and PQ documents for IRMS application including AE (Adverse Event) and Product Complaints (PC) handling modules.
  • Developed and tested BI reporting functionality for IRMS 6.12.
  • Developed and executed Performance Qualification protocol for Citrix based tool MIRS - IRMS.
  • Assisted in documentation and development of Master batch Records and SOPs for IRMS 6.12 application.
  • Technical review of pre-executed and post-executed test Scripts and defects created as part of both System Testing and User Acceptance Testing.
  • Resolved deviations occurred during the implementation of applications with the help of business and vendor and listed them in the Validation Summary Report.
  • Involved in the Data Integrity (DI) assessments of the IRMS and identified risks and non-conformance of data.
  • Performed Operational system checks that are used to enforce permitted sequencing of steps and events, if applicable.
  • Developed Validation Summary reports (VSR) for both IRMS and BI Reporting applications.
  • Assisted client with CAPA handling and Change Control processes for patient data related non-conformances.

Confidential, Hazelwood, MO

Validation Analyst

Responsibilities:

  • Performed unit testing of product specifications, sample plans, stability protocols and analysis.
  • Involved in the Change Management activities and authored master data scripts to test the subroutines are working as designed.
  • Tested the interfacing capability with various instruments like HPLC, GC-MS, Auto-titrators, EBRP (Electronic batch records), etc.
  • Worked on batch, lot (MES and LIMS interface) standard and reagent modules.
  • Documented various validation deliverable of system life cycle as required by FDA regulations under 21CFR Part 11.
  • Reviewed User Requirement Specification (URS) and developed Functional Requirement Specification (FRS) document and analyzed the causes leading to discrepancies and failure of the pre-executed OQ scripts.
  • Involved in creating and performed execution of the Installation and Operational Qualification (IQ/OQ) for the application.
  • Assessed risk and compliance issues for Data Migration activities and OQ re-execution by communicating with the help of IT and the management team.
  • Coordinated with LIMS core team, Project team, sub teams and Business Representatives to ensure SDLC deliverables are consistent and meet LIMS requirements and business needs.
  • Reviewed SOP's for the change control. Involved in developing validation deliverables such as validation Master Plan (VMP), validation protocols IQ's, OQ's and PQ's and validation summary report.
  • Loaded the Test Scripts on to the HP ALM and performed formal executions including tracing of requirements to test cases within ALM.
  • Hands-on experience in all Corrective Action Preventive Action (CAPA) related procedures.
  • Performed Operational Qualification activities for the LIMS application.
  • Analyzing the System Problem Reports and identifying execution and protocol generation errors related to the OQ and End to End Test scripts.
  • The project also involves preparing the Validation Summary Report that summarizes the validation activities that were performed for the LIMS application.Involved in preparing and writing analytical protocols, reports and technical documents.
  • Interacted with Subject Matter Experts (SME) to better understand and document the workflow and functionalities
  • Conducted the GAP Analysis to verify that the functionality matches the requirements and prepared Remediation Plans accordingly.
  • Post Go-Live supported Operational team to resolve production issues by creating change control tickets and working with developers to resolve the errors.
  • All the changes in the application were handled using change control process and testing were done to meet client procedures/requirements.

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