SUMMARY

• Over 6 years of professional experience in pharmaceutical industry in the departments of Computer System Validation (CSV)/Quality Assurance as a Validation Engineer and Validation Consultant.
• Extensive knowledge of Food and Drug Administration (FDA) regulations, 21 CFR Part 11 (Electronic Records and Electronic Signatures), Part 210 (cGMP in manufacturing, processing, packaging and holding of goods), Part 211 (cGMP for Finished Pharmaceuticals), and Part 820 (Quality System Regulation), ISO 13485/ISO 14971.
• Thorough knowledge of Software Development Life Cycle (SDLC) models especially V - shaped model and Waterfall model.
• Competent in writing, reviewing, revising and implementing Validation Deliverables.
• Expertise in performing GAP analysis, preparing Remediation Plans and Retrospective validation.
• Proficient and sound experience in Computer System Validation including Compliance Assessments and Validation Plans.
• Experienced in Gxp environments like cGLP, cGMP, cGDP, cGCP, cGAMP and developing User Requirement Specifications (URS), Functional Requirement specifications (FRS) and Design specifications (DS) as per the FDA guidelines.
• Developed and executed protocols like Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Comprehensive knowledge in developing the Test plans, Test scripts, Test cases and Test summary reports.
• Dealt with Standard Operating Procedures (SOPs) and change control procedures ensuring that they are complying with FDA regulations.
• Performed Regression, Integration and User Acceptance Testing (UAT).
• Handled Analytical instruments like the HPLC, GC, GC-MS, and LC-MS and implemented this knowledge in Laboratory Instruments Management System (LIMS) application.
• Well Experienced in Electronic Document Management System (EDMS), Laboratory Information Management System (LIMS), Adverse Events Reporting System (AERS), and Change Control Management System (CCMS).

TECHNICAL SKILLS

Validation Deliverables: Validation master plan (VMP), Validation test plan, URS, FRS, DS, IQ,OQ,PQ Protocols, Requirement Traceability Matrix (RTM), Validation summary reports, Test summary Report, system release report and Retirement plan.

FDA Compliance: 21 CFR Part 11, 820, cGxP (cGMP, cGAMP, cGDP, cGLP), IQ, OQ, PQ, RTM, SOP, Work Instruction, Change Control, Risk Assessment.

Operating systems: Windows XP, 98/95/2000/2003/ Vista.

Tools: MS Office (Word, Excel, PowerPoint, Access) MS Visio, MS Project.

Bug tracking and Reporting Tools: Quality Center

Applications: LIMS, AERS, EDMS, CCMS.

PROFESSIONAL EXPERIENCE

Confidential, Dayton, NJ

Validation Engineer

Responsibilities:

• Involved in documenting all aspects of the computer systems validation lifecycle, in accordance with FDA regulations, particularly 21CFR Part11.
• Written and executed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) test scripts for different modules of LIMS based on the User and Functional Requirement specifications.
• Involved in developing Design qualification (DQ) based on User Requirement Specifications and Functional Requirement Specifications.
• Reviewed the User Requirement Specifications (URS) and the Functional Requirement Specifications (FRS) documents and analyzed the causes leading to discrepancies and failure of the pre-executed OQ scripts in compliance with GAMP and 21 CFR part 11 guidelines.
• Performed the GAP Analysis of the current system and prepared Remediation Plan.
• Responsible for working with all phases of SDLC in the Validation process of LIMS.
• Written and executed PQ test scripts for data migration process in updating LIMS.
• Developed and updated the Requirements Traceability Matrix (RTM) to track requirements during the QA Testing Phase.
• Developed test plans, test strategies, test scripts for validation testing along with the Test Summary Report (TSR).
• Revised Standard Operating Procedures (SOPs) to govern the development, change management, testing, release, deploy, training, document control in its software Development Life Cycle (SDLC)
• Logged errors on the error tracking system and re executed the test cases upon resolution.
• Responsible for validating the reports generated by the LIMS application are in compliance with 21 CFR part 11 requirements
• Performed admin services by providing log in access, permission grants, maintainance and periodic review of user accounts in LIMS.
• Attended weekly status meetings with Team lead, Project Manger and Subject Matter Experts to update work progress.
• Participated in project meetings involving various departments to ensure that current validation best practices and compliance expectations are integrated into written protocols by providing guidance on applicable regulations, internal policies.
• Responsible for writing Work Instructions for Change control.

Confidential, New Brunswick, NJ

Validation Engineer

Responsibilities:

• Supported Validation activities for the software and manufacturing equipment (granulators, FBD, blenders, compressors, encapsulators and coaters) validation.
• Developed Validation plans for implementing validation activities with regards to computer system and equipment validation.
• Used waterfall model of SDLC to design computer systems validation activities to be compliant to FDA regulations such as 21 CFR Part 11.
• Interacted with various departments such as change control, manufacturing, IT, Analytical, and QA to develop MVPs and scheduling.
• Involved in assigning change control numbers and maintaining change control logs. Assisted in circulating the validation documents for review by SME.
• Developed Change Impact assessment and risk assessment documents to provide justifications for the validation activities.
• Involved in assigning validation activities to team members based on their skills and requirements.
• Maintained and validated spreadsheets to track the updates from team members and report it to the management on a weekly basis.
• Prepared and updated Requirements Traceability Matrix (RTM).
• Review allcomputersystemvalidation(CSV) documents for manufacturing facilities to determine compliance with cGMP.
• Performed GAP Analysis between Analyst v.4.0 and previous versions and also developed Remediation Action Plans for it.
• Prepared PQ/UAT test plan, Test Scripts and Test Reports according to the User Requirement Specifications (URS) and Functional Requirement Specifications (FRS)
• Revised Standard Operating Procedures (SOPs) to govern the development, change management, testing, release, deploy, training, document control in its software Development Life Cycle (SDLC)
• Involved in maintaining Deviation reports and CAPA using Trackwise 8.
• Prepared and maintained document history files using Documentum.
• Troubleshooted issues that arose during execution of validation protocols by reviewing and approving root cause, deviation report, recommending corrective/preventive action.
• Generated and reviewed final validation reports at the end of the process and coordinated in the approval.
• Kept track of validation deliverables such as URS, FRS, DRS, IQ, OQ, PQ and validation reports.
• Performed Unit Testing, Integration Testing and System Testing and Regression Testing.

Confidential, Mansfield, MA

Validation consultant/ QA Analyst

Responsibilities:

• Reviewed and modified existing Standard Operating Systems (SOPs) for Document management system (DMS), System Administration, Change Control Procedures and Testing SOPs.
• Responsible for analyzing and reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification and System Design Specification document.
• Worked on change control process by opening a Change Request Form (CRF), preparing and authorize Change Control Implementation Plan and Change Control Summary Report.
• Identifying and assess impact of Change control activities for validated software and systems.
• Prepared Installation Qualification (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) protocols using standard templates and SOPS.
• Executed and verified test results, identified and reported issues and provided test summary reports.
• Wrote and reviewed Requirement Traceability Matrix (RTM).

Confidential, Davie, FL

Validation Analyst/Technical Writer

Responsibilities:

• Reviewed and modified standard document templates for validation deliverables like Validation Plan, User Requirement, Design Specification document.
• Gathered the requirement specifications from the business community and conducted a two-way communication with the development team and business team on priority and impact analysis.
• Developed process flow charts using MS Visio.
• Created and updated requirement traceability matrix to ensure that all the requirements are fulfilled for testing.
• Written and executed Installation Qualification (IQ) and Operational Qualification (OQ) test scripts in accordance with 21 CFR Part 11.
• Developed test plans, test strategies, test facility requirements, test scripts for validation testing.
• Performed Gap Analysis, analyzed alternatives and documented Incident Recovery SOP.
• Developed and documented Working Instructions for different users of the application.
• Coordinated and conducted the team meetings and prepared the status reports on the progress of the project.
• Captured the meeting minutes and documented the lessons learned for historical records.

Confidential

QA Analyst

Responsibilities:

• Designed and executed protocols for IQ and OQ of Media preparation vessels, Transfer line and CIP/Waste carts to validate manufacturing equipment, facilities, and utilities following the latest cGMP regulations.
• Developed sound scientific rationale and implementation plans for each validation protocol.
• Assessed the impact of changes to validated systems and wrote protocols to bring systems into compliance.
• Evaluated test data and wrote final reports to summarize testing performed.
• Gathered and reviewed pertinent documentation required for completing the validation activity.
• Communicated the requirements, scheduling, results and impact of the performance of the above projects to ensure efficient and successful turnover of validated equipment or systems to the customer in support of the manufacture of sterile pharmaceuticals.