SUMMARY

• 7+ years of experience in Pharmaceutical Environment with expertise in Computer System Validation (CSV), Equipment Qualification, Testing and Technical Writing with strict adherence to GAMP &cGMP regulations.
• Extensive experience in Information Technology, Computer SystemValidation(ERP/Quality Systems, Manufacturing, Adverse Event Reporting system (ARGUS) LIMS and Lab systems, Quality Assurance and Business Analysis.
• Experience in developing protocols, Executing tests plans Data migration plan and Constructing Test Summary Reports.
• Experience in QA review and guide on quality issues that affect the integrity of the system.
• Strong experience of validation & integration of Quality Management System, Scientific Data Management System (SDMS), Learning Management System, Document Management System, Laboratory Information Management System (LIMS), Adverse Event Reporting System (AERS), Trackwise&Documentum.
• Experience drafting new SOPs and trained users on SOPs for various systems.
• Knowledge and understanding of 21 CFR Part 11, 50, 56, 58, 210, 211, 820, and associated FDA Regulations and EU guidelines.
• Professional experience in validation practices with good understanding of cGxP (cGMP, cGLP, cGDP, and cGCP) standards, Corrective and Preventive Actions (CAPA) Investigation.
• Experience in Implementation of custom build software.
• Expertise in conducting Gap Analysis, Remediation plan.
• Strong working knowledge of Windows Servers and Operating Systems.
• Experience in the operation and working theory of lab scale analytical equipment’s - GC, HPLC, Autoclaves, Ovens, Incubators, Plate Reader, ICP Mass Spectrophotometer and Lab Instruments (Conductivity meter, pH meter).
• Experience with managing records using SQL.
• Excellent working knowledge experience in Validation Life Cycle, Software Development Life Cycle, Manual Testing.
• Experience in Test Management, Bug Tracking and Reporting Systems.
• Excellent oral and written communication skills Strong expertise in interviewing and interpret communication requirements of team members.
• Expertise in using SQL for data validation and manipulation, worked on queries to perform backend testing.
• Tracked and documented Change Requests using HP Quality Center.
• Excellent documentation skills in compliance with Good Documentation Practices (GDP).
• Excellent Organizational, Interpersonal, Written, and Oral communication skills.
• Experience in Software Testing Methodologies.

TECHNICAL SKILLS

Life Sciences: 21 CFR Part 11, cGxP (cGMP, cGDP, cGLP), GAMP, IQ, OQ, PQ, RTM, SOP, Summary Reports, Audit Trails

Testing and Tracking Tools: WinRunner, LoadRunner, Test TrackProLanguages C, C++, FORTRAN, HTML

Operating Systems: Windows 95/98/2000/ NT, UNIX

Databases: SQL, Oracle, Microsoft Access

Analytical software: SQL* LIMS

Scientific Software: MATLAB, MAPLE, ChemCAD

Other Tools: MS Office, MS Visio

PROFESSIONAL EXPERIENCE

Confidential, NY

Validation Engineer

Responsibilities:

• Reviewed Business Requirements and prepared Validation Master Plan to implement SQL LIMS.
• Configured the system according to user requirements.
• Documented all aspects of Computer System Validation in accordance with cGMP, cGLP and cGCP guidelines and 21 CFR Part 11.
• Assessed the risk involved in adding modules
• Involved in documentation and execution of Installation Qualifications, Operational Qualifications, and Performance Qualifications.
• Performed Manual Testing for Front-End Functionalities and Back-End Operations.
• Used SQL Queries for backend testing.
• Analyzed Test Scripts to ensures compliance with 21 CFR parts 11 with respect to Audit Trail, Data Integrity and Data Security of the application.
• Ensured Calibration of all laboratory equipments like GC, HPLC, Autoclaves, Ovens, Incubators, ICP Mass Spectrophotometer and wrote SOPs for calibration and maintenance of these equipments.
• Validated computer systems using cGMP, cGLP and cGCP guidelines.
• Made Deviation and Failure Investigationsfor the deviations found in the system.
• Prepared Deviation Report.
• Conducted GAP Analysis to access the company’s current compliance status against FDA’s guidelines.
• Drafted Remediation Plan for the project as part of a team.
• Designed, developed and implemented Test Plans, Pre/Post executed scripts using the detailed business requirements document.

Confidential, NJ

Validation Analyst

Responsibilities:

• Created and executed test cases for new TrackWise modules (Internal and External Audits).
• Prepared and maintained the Validation Strategy Document (VSD), Standard operating procedure (SOPs) and Validation Summary Report.
• Involved in preparing documentation for all aspects of the computer system validation lifecycle, in accordance with FDA regulations, particularly 21 CFR Part 11 including Installation Qualification (IQ) Specification, Operation Qualification (OQ) Specification, Performance Qualification(PQ) Specification.
• Maintained and documented SOPs.
• Coordinated with the system Analyst, Project manager and Business Analyst to set up the Pre- validation and validation Environment to execute the scripts.
• Developed Requirements Traceability Matrix (RTM) to track requirements and to align the work process.
• Involved in developing and implementing the test strategy and performed various analyses.
• Developed FRS (Functional Requirement Specification) and DS (Design Specification) from the URS (User Requirement Specification).
• Developed GAP analysis, Remediation Plan, maintenance of hybrid systems, closed and open record systems.
• Drafted SOP’s and trained users on these systems and the implications and impact of 21 CFR Part 11 complaint data systems on the day-to-day functions.
• Involved in preparing compliance report about the existing status of cGMP, cGCP, cGLP.
• Regular interaction with designers, developers and system analysts.

Confidential, MA

Validation Engineer

Responsibilities:

• Developed a Validation Master Plan (VMP) to document the intent of validation effort in accordance with FDA regulation.
• Developed SOPs and IQs, OQs, PQs for validation of Computer systems specifically for the Electronic Records and Signatures.
• Reviewed test cases and scripts and documented the results as per the FDA regulations.
• Performed Gap Analysis and prepared Remediation Plans to fix the gaps identified.
• Assessed 21 CFR Part 11 requirements and analyzed organization’s current validation state.
• Monitored the Design, Manufacture and Installation of all medical devices in the process to satisfy 21 CFR 820 regulations.
• Prepared and reviewed Validation Summary Repot (VSR) to summarize the overall validation effort.
• Reviewed documents (Project Plan, Test Plan, Test Cases) and provided input on documents pertaining to Migration of Relsys ARGUS 2.9, as the system will be upgraded to v4.2.
• Tracked the training records of individuals (Project Manager, Technical Lead, Document Liaison) working on the projects.
• Reviewed & Approved the documents related to the Projects:
• Project Plan, Communication Plan, Deployment Plan, De- Deployment Plan Test Plan, Test Cases, Test Matrix, Qualification Documents (IQ,OQ, PQ & UAT), System Disaster Recovery Plan, Meeting Minutes - Phase specific ( Plan, Design, Build, Qualification & Release )
• Prepared the Compliance Report (Summary Report) upon Project completion.
• Provided Mitigations to the issues involved considering the Regulatory Guidelines.
• Created Summary Reports for all the projects as part of a close out report stating the issues & risks mitigation and track down of all deliverables created, their completion and approval.

Confidential

Validation Test Engineer

Responsibilities:

• Responsible for the overall coverage of requirements of User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
• Responsible for allocation of test assignments to the team members.
• Collaborated with the Validation Manager for shaping up the Validation Plan.
• Involved in Execution of the Test Scripts and writing Test Summary report.
• Worked as Test Coordinator during Execution of the scripts.
• Responsible for developing the Requirement Traceability Matrix.
• Responsible for the management of Deviation Handling documents
• Performed Risk Assessments to verify whether the systems are Quality impacting.