SUMMARY:

• Diversified 8+ Years of experience as a Validation professional in the pharmaceutical industry, known for the ability to develop and implement processes that positively impact the compliance results.
• Strong understanding of 21 CFR Part 11 drug GXP requirements including electronic records, electronic signatures, system validation strategies and documentation.
• Working experience in FDA regulated environment and research laboratories with good understanding of cGxP (cGMP, cGDP, cGLP) standards and Risk based validation.
• Competent in quality system and standard 21 CFR (parts 11, 210, 211, 820), ISO 13485 and GAP Analysis.
• Good knowledge of Software Development Life Cycle (SDLC), familiar with Software Methodologies like Waterfall, Spiral, V - Model and Agile in relation to development and testing.
• Experience in reviewing and developing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA rules and regulations.
• Expertise in developing the validation protocols, executing tests, and construction of Validation Summary Reports for IQs, OQs and PQs.
• Well versed with GAMP 4 & GAMP 5 guidelines.
• Experienced in classifying the computer system applications based on GAMP categories (GAMP5; GAMP4; GAMP3) including risk-based approach.
• Experienced in drafting new SOPs & users on SOPs for various systems.
• Configured changes including updates to global change control process.
• Expertise in preparing Risk Assessment, Remediation Plan and Deviation Reports for FDA regulated environment.
• Sound knowledge of clinical trial processes and clinical d Confidential management practices.
• Experience in reviewing Corrective and Preventive Actions (CAPA) and highlighting and suggesting the remediation plans to mitigate the non-compliance.
• Developed comprehensive Test Plans, Test scripts, Test Case and Test Reports. Performed Regression, System and UAT testing using both HP QC, HP ALM and paper based manual testing.
• Proficient in dealing with Change control management systems, Laboratory information management system (LIMS), Enterprise document management system (EDMS).
• Hands on experience in tools like HP Quality Center, HP ALM and Documentum.
• Good experience with MS Visio in developing flow charts and flow diagrams.
• Excellent communication, writing and interpersonal skills and strong ability to perform individually and also as part of team.

TECHNICAL SKILLS:

Validation deliverables: Validation Master Plan (VMP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Functional Risk Assessment (FRA), Requirement Traceability Matrix (RTM), IQ, OQ, PQ (Test Plans, Test Cases, Test Summary Report), Validation Summary Report (VSR)

Regulations: FDA Quality system regulations, 21 CFR (part 11, 210, 211, 820), ISO 13485 and GxP practices

Software Applications: TrackWise, Service Now, eTMF, LIMS, HP ALM, HP QC, EDMS

PROFESSIONAL SUMMARY:

Confidential, Redwood City, CA

Validation Engineer

Responsibilities:

• Responsible for assisting in the implementation of software systems in conformance with regulatory requirements as they pertain to 21CFR part 11.
• Responsible for electronic Trial Master File (eTMF) Software implementation documentation
• As part of eTMF Implementation performed GAP analysis to determine the validation deliverables.
• Performed Computer System Validation (CSV) activities like protocol executions, author, review and approval of specifications (user, functional and design), risk assessments and qualification testing.
• Provided Technical Writing expertise in updating Standard Operating Procedures and Validation Life Cycle documents and ensure d Confidential accuracy and integrity.
• Created and executed Installation Qualification (IQ), Operational Qualification (OQ), performance Qualification (PQ) scripts for all GxP systems in HP ALM.
• Ensured that planned/unplanned changes, deviation documents are reviewed and documented as per change control SOP’s
• Used ServiceNow application to manage Change Control management process and documented all validation deliverables as per technical impact and business impact assessment.
• D Confidential Integrity Assessments and responsible for creating D Confidential integrity Remediation plans in electronic document management systems (EDMS).
• Conducted risk assessment meetings with stake holders and determined the system risk by calculating the risk priority number (RPN).
• Managed defects and performed post-resolution follow-up activities to ensure problems have been adequately resolved.
• Authored test summary report at the end of validation processes and reviewed Requirement Traceability Matrix to ensure user requirements and design elements are fully tested and there were no gaps.
• Provided Validation services to ComplianceWire Learning Management System (LMS), CIRRUS eDMS (electronic D Confidential Management System) systems, including the management of upgrades to new systems releases in a regulated environment
• Review and analyze artifacts and deliverables throughout the SDLC life cycle.
• Performed GAP Analysis and Periodic Reviews and documented all action items.
• Collaborate with multi-functional teams like QA, Clinical Operations and QC teams for continuous improvement and maintenance of quality standards.
• Manage multiple system vendors on releases/upgrades and perform necessary User Acceptance Testing or Regression testing for deployment of changes

Confidential, Stockton, CA

Validation and IT Compliance Lead

Responsibilities:

• Responsible for assisting in the implementation of Electronic D Confidential Capture (RAVE EDC) in conformance with regulatory requirements in 21CFR part 11.
• Wrote Computer System Change Assessment, Compliance Analysis, User Requirement Specifications, and User acceptance test scripts for MES (Manufacturing Execution Systems) and SAP integration project.
• Developed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) Scripts.
• Authored D Confidential Migration Plan and Summary documents for MES project.
• Developed Traceability Matrix and Validation Summary Reports as part of Validation Deliverables.
• Analyzed the applicability of GxP Requirements, 21 CFR Part 11 Requirements for the computer systems.
• Developed test plans and test protocols for system test and UAT Test in the implementation of sample management module in LIMS.
• Prepared, Reviewed and updated SOPs to ensure compliance with regulations and current practices.
• Executed the test cases using HP Quality Center and documented results as part of IQ, OQ and PQ
• Executed test cases based on the test plan and in accordance with Good Documentation Practices (GDP).
• Reviewed pre and post executed integration test scripts, end-to-end test scripts, OQ test scripts and user procedures.
• Used TrackWise application to handle Change Control management documents, CAPA, Work instructions and complaint handling.
• Actively participated in project meetings providing valuable inputs related to the regulatory requirements such as, Part 11 Electronic Records and Electronic Signature compliance and importance of documentation, project deliverables, and validation deliverables.
• Perform extensive technical reviews and interpret d Confidential for accuracy

Confidential, San Diego, CA

Validation Engineer

Responsibilities:

• Involved in all the aspects of Systems validation lifecycle and created validation deliverables in accordance with the FDA regulations, particularly 21 CFR Part 11, GLP and GMP.
• Worked on both GxP and Non-GxP systems
• Experienced in writing test scripts for complex requirements.
• Interacted with QA Engineers for Quality review of Validation Documents.
• Authored and reviewed test cases related to multiple modules of TrackWise and conducted the required testing of applications using HPALM tool
• Good working knowledge in DIET (Defect, Incident, Enhancements tracking tool), a change management system.
• Followed all the SOPs required to the standard procedures for change requests, DIET system, HPALM.
• Responsible for Authoring and reviewing Traceability matrix document, System Assessment documents.
• Good knowledge in using Electronic Document Management System (Documentum) to route the documents for review and approval.
• Provided technical writing abilities for developing controlled documents involved with new computer systems implementations, change controls and other deliverables of computer systems validation.
• Provided technical writing support for IT Quality Management activities.
• Organized, standardized and maintained workflow of documents in validation lifecycle structure including change controls.
• Developed documentation to capture User Requirements, Functional Requirements, Design Documents, IQ/OQ/PQ Test Scripts, Validation Plans and Summary reports, system manuals, SOPs, etc. in an efficient manner.
• Responsible for authoring Validation plan, summary report and system release memo for TrackWise and EDMS.
• Reviewed all the documentation from SDLC deliverables such as URS, FRS, IQ, OQ, PQ pre and post executed scripts.
• Scheduled team meetings with System Owner and Quality manager to track the workflow of the documents related to TrackWise.

Confidential, San Diego, CA

Validation Analyst

Responsibilities:

• Generated, Reviewed and revised site governing Standard Operating Procedures (SOPs) for Laboratory and Pharmaceutical equipment per analytical chemistry and equipment scope in manufacturing.
• Executed validation and Qualification protocols which include installing, operating and maintaining of Lab Equipment and Instruments (HPLC, UV-Vis Spectrophotometer, pH/Conductivity meters, Balances) and ELISA spreadsheet validation.
• Executed Qualification protocols and analysis of d Confidential generated from instruments such as HPLC, Spectrophotometers for continuous improvement of Quality Systems.
• Perform 21CFR 11, GxP, D Confidential integrity assessments for computerized and standalone lab instruments to follow and other regulatory guidelines.
• Responsible for analyzing and reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification, System Design Specification documents for Empower and ELN (Electronic Lab Notebook) implementation projects.
• Proficient in documenting d Confidential and maintaining detailed reports in electronic lab notebook (ELN).
• Responsible for writing and reviewing test plans, test scripts and executing them for validation testing of waters Empower.
• Responsible for method development and validation of finished product as well as supporting testing and approving of release product
• Documented Installation Qualification (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) documents using standard templates.
• Experienced in testing of Lab Management applications like LIMS.
• Developed applicable test cases for integration test, system test and acceptance test. Defects were tracked while processing testing and reported using Test Director.

Confidential

Technical Writer

Responsibilities:

• Designed, developed, tested and implemented EMBRs (Electronic Master Batch Records), in accordance with the company's Quality Systems, FDA compliance, and other regulatory standards.
• Lead the analysis of the Batch Record requirements and developed EMBRs, design documents and test scripts in accordance with SOPs (Standard Operating Procedures) and SME (Subject Matter Experts) input.
• Developed the design process including gap analysis, design document creation, and prototype development to support design reviews.
• Demonstrate an understanding of automation, PLC, Software and Hardware engineering
• Experience with Electronic D Confidential Management Systems
• Ability to establish clear priorities quickly
• Trained end users in batch record execution.
• Good experience in Gap Analysis and documenting Remediation Plan
• Used HPQC Quality Center for the testing and also for tracking and reporting test defects
• Developed and revised SOPs, using document management tool to control review and approval cycles.