SUMMARY

• 7 Years’ experience in Validation Engineering in FDA regulated Pharmaceutical GxP environment with concentration in CSV (Computer System Validation), Process Validation, Technical Writing, and Testing.
• Good knowledge of SDLC (Software Development Life Cycle),acquainted with Software Methodologies like Waterfall, Spiral, V - Model and Agile in relation to development and testing.
• Good understanding of the development and review of executed protocols and final CSV reports.
• In depth knowledge of FDA regulations21CFR part 11, 210, 211 and 820 and GxP regulations.
• Good understanding of GAMP 5 and Corrective and Preventive Actions (CAPA) Investigation.
• Expertise in developing and documenting all the Validation Master Plan (VMP), Standard Operating Procedures (SOP), Installation Qualification (IQ),Operational Qualification (OQ),Performance Qualification (PQ) and Validation Summary Report (VSR).
• 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 regulation.
• Excellent knowledge and good working experience on preparing the Risk Assessment documents.
• Experience in developing and writing Requirements Traceability Matrix (RTM).
• Excellent working knowledge in Electronic Records Management System(ERMS),SAP validation, TrackWise, Inventory management system (IMS), Laboratory Information Management Systems (LIMS), Documentum, Scientific Data Management System (SDMS) and Adverse Event Reporting System (AERS).
• Good experience knowledge of test executions using HP ALM and HP QC.
• Experienced in drafting new SOPs& training users on SOPs for various systems.
• Experience in Change Control procedures for software applications.
• Good knowledge ofGap analysis and preparing Remediation Plan.
• Experience in writing and developing Test Plans, Test Scripts, Test Criteriaand Test Summary Reports for different types of testing.
• Excellent documentation skills with knowledge of Good Documentation Practices (GDP).
• Excellent communication, writing and interpersonal skills and strong ability to perform as part individually and also as a part of team.
• Knowledge in handling various analytical instruments like HPLC, TLC, LC, GC, column chromatography, UV-Visible Spectrophotometers, flame photometer and FTIR.

TECHNICAL SKILLS

Validation: 21 CFR Part (11, 210, 211, 820), GAMP, cGMP, GDP, GLP, IQ, OQ, PQ, RTM, SOPs, Summary Reports, LIMS, TrackWise.

SDLC: V-Model, agile model, Waterfall.

Testing tools: HP Quality Center.

Tools: Word, Excel, PowerPoint, Access, Visio, Outlook, Sharepoint.

Operating Systems: Windows 95/98/2000/XP/Vista/7, 8, Macintosh.

PROFESSIONAL EXPERIENCE

Confidential, Fort Washington, PA

Validation Analyst/ Technical writer

Responsibilities:

• Involved in CRIM Legacy System Data Migration project, migrating data from GIFTS and TRIM legacy systems to ERMS.
• Involved in the System Testing for data migration to ERMS using HP ALM.
• Responsible for writing test plans, test scripts and execution of scripts in compliance with FDA regulations.
• Authored and reviewed IQs for Cognos Reports.
• Involved in the development and review of test scriptsfor ST and UAT of ERMS.
• Guided the business users to execute the UAT scripts in QA and Production environments.
• Experienced in the post execution review of ST and UAT.
• Review and development of ERMS data migration FRS in compliance with GDP.
• Involved in System testing of Cognos Reports.
• Prepared the Datasheets and Data Extracts for ST and UAT using FRS and source database.
• Performed peer reviews of the test scripts and test executions in HP ALM.

Confidential, Schenectady, NY

Validation Analyst

Responsibilities:

• Involved in the development of Master Test Plan to test SAP modules to meet the requirements defined in FRS.
• Created the Test strategy document for testing SAP modules.
• Extensively used TrackWise in reviewing and updating validation deliverables, protocols to ensure compliance with company policies and procedures.
• Involved in system testing of Event management module in TrackWise.
• Create and maintain change control and CAPA management activities in TrackWise.
• Developed test plans and test scripts for the Functional and Regression Testing.
• Involved in executing the test scripts of SD, MM, PP, WM, IM modules of the SAP implementation.
• Developed test plans and test casesfor procure to pay, order to cash and MM.
• Followed good test practices to document the test evidence, Deviations, Resolutions and Corrective Actions in the TrackWise system.
• Involvedin the training of the business users to execute the scripts as part of User Acceptance Testing (UAT).
• Used TrackWise to initiate and approve validated system change requests.
• Executed and reviewed the test scripts for new SAP transactions, Customized transactions, tables.
• Developed the Test Scripts to generate the Audit Trail reports to verify the creation and modifications to the records are captured in audit trail table logs.
• Involved in the execution of the test scripts to test the interface between SAP and LIMS systems.
• Involved in the implementation and Validation of Global IT application TrackWise -CAPA andCCM Workflows.

Confidential, Irvine, CA

Validation Analyst

Responsibilities:

• Involved in gathering the business requirements from the business process Owners.
• Authored VMP with risk based approach for validation.
• Developed and maintained all validation deliverables in the TrackWise system.
• Developed FRS and DS from the URS.
• Responsible for authoringValidation Plan, OQ/PQ protocols and Validation Summary Report.
• Used MS Visio for pictorial representation of the Design Specifications and workflow of the process.
• Involved in documenting Vendor Assessment Reportfrom a list of AERS suppliers.
• Responsible to get QA approval for validation deliverables and Vendor Audit.
• Used TrackWise tool for Quality management issues and tracking applications for CAPA.
• Developed RTM to trace requirements to their respective design specs, technical specs and test scripts or SOPs.
• Attended Issue meetings to address and verify bug fixing and update bug report.
• Reviewed Migration plans, Migration Verification scripts and documented migration summary report.
• Responsible for writing change controlSOP’s to comply with 21 CFR Part 11 requirements.
• Developed test plans, test strategies, test scripts for validation testing.
• Performed change controlin TrackWise system by assessing proposed changes to validated processes.
• Conducted GAP analysis and prepared Remediation Plan
• Responsible for developing test protocols for audit trail, time stamp and electronic signature for the work flow of documents.
• Performed Data migration using Migration utility tool and prepared migration snapshots for data backup.
• Prepared training documentation for the various SOP training.
• Hands on experience in documents review and approvals in QA aspects.

Confidential, NJ

Validation Engineer

Responsibilities:

• Documented Design Specifications, User Requirements, Installation Plan, System & UAT Test Scripts, deliverables for change control of LabWare LIMS.
• Related electronic files were attached as reference documents using TrackWise so that they can be reviewed along with the overall request.
• Developed, reviewed and executed test scripts for the system testing of the IT infrastructure components.
• Reviewed the system related SOPs to ensure compliance of company’s policies and procedures.
• Involved in Risk Assessment of various laboratory Instruments interfaced to LIMS.
• Performed peer reviews of product documentation.
• Developed and reviewed Test Procedures & Operational Qualifications for validation in compliance with 21 CFR part 11 regulations.
• Involved in drafting and approval of URS for all kinds of Laboratory equipment.
• Involved in documenting EQP, Calibration Assessment and Calibration procedure for the laboratory instruments.
• Developed the Validation Assessment documentproviding an overview of objectives to be covered during validation.
• Involved in the development of RTM to track requirements and test cases.
• Involved in the validation of computerized laboratory equipment like Atomic Emission Spectroscopy based on GAMP 5
• Involved in the process of change control management.
• Involved in the review and execution of test scripts for User Acceptance Testing.
• Analyzed and wrote the test scripts for Integration test to validate LIMS modules.
• Developed and reviewed the summary report and the final system acceptance documents.

Confidential, Morristown, NJ

Validation Analyst / Compliance Analyst

Responsibilities:

• Performed requirements gathering sessions with users for Inventory Management System (IMS).
• Prepared list of documents required for the IMS legacy system based on GAMP 5.
• Recommended Validation Deliverables and level of testing to be conducted for the IMS system.
• Conducted GAP Analysis in order to be in compliance with 21 CFR Part 11.
• Analyzed the requirements, critical areas of the IMS application and performed risk assessment.
• Documented and reviewed the Project plan.
• Developed various validation deliverables required in this project in compliance with 21 CFR Part 11.
• Guided team members to follow the FDA regulations for electronic records and signatures as defined in 21CFR Part 11.
• Review documents related to Quality Systems such as User Training Materials.
• Excellent understanding of various Inventory Management Systems and how their components are interfaced together to facilitate seamless transition of data within a particular domain.
• Review internal documentation for compliance with regulations and industry guidelines.
• Involved in drafting Remediation Plan after Gap Analysis for IMS System.
• Created validation schedules, coordinate execution efforts with operators, engineers, lab scientists and quality assurance staff members.
• Involved in CAPA management workflow.

Confidential

Technical Writer/QA executive

Responsibilities:

• Involved in the testing and implementation ofEMBRs (Electronic Master Batch Records), in accordance with Quality policies of the company and FDA compliance.
• Involved in the analysis of the requirements and authored test scripts for testing EMBRs.
• Developed and implemented Quality Plan for the process.
• Involved in the process of Performance Qualification ensuring the system meets the user requirements.
• Conducted Gap analysis and involved in the change control process.
• Reviewed and approved the test plan and test scripts.
• Ensured all the project team members followed the company’s policies and procedures, other regulations.
• Guided the end users in execution of the test scripts and involved in post execution reviews.
• Revised SOPs and related documents using document management tool to control review and approval cycles.
• Reviewed all the documents are in compliance with the FDA 21 CFR part 11 regulations.
• Interacted with the Quality Assurance Manager to present documentation for quality control inspection.

Confidential

Quality control

Responsibilities:

• Involved in the testing of in-process and finished product samples.
• Reviewed log books for instruments used for analysis.
• Checked and maintained dissolutions.
• Verified all the necessary testing that was carried out systematically and correctly.
• Ensured collection of in process, intermediate and finished sample of the product being manufactured.
• Involved in drafting the process specifications.
• Calibrated laboratory instruments like HPLC, Spectrophotometers, Fermenter, Autoclave and Reactors.
• Maintained the documents as per GMP, WHO and MHRA regulations.
• Review, Change and Distribution of SOP’s, Specifications and Quality Formats.
• Involved in the SOPs documentation and initiated change control process
• Ensured environmental conditions are maintained in respective area of the operation.
• Maintained cleanliness and sanitation of manufacturing area.