SUMMARY

• Experienced professional with extensive experience in Quality Assurance/Compliance and Validation - validating computer system applications/Laboratory systems/medical devices/equipment(s).
• Managed validation of Computer System applications, Laboratory Systems, Medical Devices, System Interfaces, and Clinical Response Criteria’s for evaluation of Clinical Studies for compliance with GxP, EMEA, SOX, IT Security, Data privacy, FDA, FMEA and ISO requirements as applicable.
• Equipment Qualification and interfaces with system(s) and device(s) for verification of data accuracy/precision (QC) and acceptability for applicable business processes.
• Developing System Development LifeCycle (SDLC) methodologies to accommodate the implementation processes for: computer system applications, laboratory systems, infrastructure, medical devices and equipment.
• Responsible for the coordination and management of the validation projects and master validation plans.
• Responsible for creation, review and approval of SDLC validation deliverables to ensure adequacy of validation effort in compliance with the company standards and regulatory requirements.
• Responsible for creation, review, approval and management of the global and system-specific Standard Operating Procedures (SOPs) to support manual processes around system usage to ensure regulatory and company requirements are met.
• Responsible for interacting with the business, Information Technology (IT), Computer System Validation (CSV) units, consultants, as well as third party service providers (vendors), during the initiation, development, build, and implementation of computer applications, Lab systems, Processes and Products to ensure compliance/regulatory, data integrity and company standard requirements are met.
• Responsible for process development for product release and launch to market.
• Responsible for strategizing the validation/remediation process through Gap Analysis, Risk and Regulatory Compliance assessments.
• Responsible for system release to production following Change Controls, CAPAs, Periodic Reviews and Retrospective remediation’s.
• Provide quality support in Drug Product GMP operational areas, including change control, deviations, OOS investigations, root cause analysis, corrective actions and preventive actions (CAPAs), complaints, and training.
• Responsible for the validation impact assessment regarding changes to validated systems and processes in production.
• Standardization of validation process and testing strategies using application lifecycle and testing tools to support global applications/systems deployments and Change Control process.
• Managed the execution of approved validation and qualified protocols and associated test scripts.
• Responsible for standardizing the clinical data assessment criteria’s and validating the Oracle Clinical studies based on the standardized criteria’s
• Maintain organization and archival of completed validation and qualified document packages.
• Responsible for providing guidance to the IT /business team(s) on the validation and regulatory requirements
• Responsible for providing guidance to the IT team on creation of global and system - specific SOPs.
• Responsible for managing, directing and coordinating activities related to the validation cycle for computer system products (applications) - in-house, vendor supplied or COTS.
• Responsible for ensuring that efficient procedures and practices are followed for validating the computer system product in a timely manner
• Providing trainings on CSV and GxP procedures and policies to system users, IT and third-party vendors.
• Responsible for escalation of project-specific issues, from a quality assurance and compliance perspective to applicable teams.
• Responsible for preparing the project timelines, managing resources & schedules for ensuring project prioritization and associated projected timelines are met.
• Conducted complex audits (as lead auditor) of Products, Processes, Systems and Vendors as assigned and in accordance with the Audit Plan.
• Conducted internal audits of sponsor-specific Oracle Clinical (OC) studies to ensure consistency and conformance to industry practices and standards.
• Draft and impart audit management training for subject matter experts.
• Coordinate pre-audit and inspection documentation including streamlining information needed from applicable teams and departments.
• Improve and implement efficient methodologies and tools for handling audits and inspections.
• Compiled internal Audit Reports to detail and elaborate the audit findings and communicate the same to the management and applicable teams.
• Maintained Corrective and Preventative Action (CAPA) system for findings/observations due to audits, inspections, and quality events, including developing reports for trend analysis.
• Accountable for answering FDA Audit findings and concerns as a Subject Matter Expert (SME) and Validation Manager.
• Responsible for providing insight regarding the validation status of the systems, processes and procedures to assist in compiling the Audit Plans.
• Maintain oversight and facilitate resolution of CAPA from audits to prevent repeat or complex resolution to findings by liaising with applicable departments.
• Conducted Periodic Reviews to ensure the compliant state of the systems, processes and products with company standards and regulatory.
• Complied and implemented Remediation Plans following the Change Control to ensure the validated and compliant status of the systems, processes and products.
• Conducted detailed Root Cause Analysis of Quality System non-compliances to identify and implement sustainable corrective actions via Corrective and Preventive Action (CAPA), Deviations, Notice of Non-Conformance.
• Responsible for process improvements to increase the efficiency and effectiveness of periodic reviews and investigations.
• Conduct trend analysis of non-conformances, CAPA, complaints, APR, and other quality indicators.
• Assure all systems, processes and procedures are in conformance with the national and international guidelines/requirements.
• Ensure all quality records are maintained for easy retrieval as applicable.
• Responsible for providing regulatory and compliance guidance to teams as Quality Computer System Validation (QCSV) for strategizing and planning associated validation/quality efforts.
• Created global and department specific SOPs and provided guidance to the teams for the same

TECHNICAL SKILLS

Programming Languages: PL/SQL, SQL*Plus, Java

Requirement and Tools: JIRA, HPQC, HP ALM, Confluence, SharePoint, Selenium

Web Technologies: HTML, JSP, Client-Server Programming, webMethods

Operating Systems: SunOS, HP, Windows

PROFESSIONAL EXPERIENCE

Confidential

Principle Validation Engineer

Responsibilities:

• Clinical Study Data Management System (Oracle Clinical (OC)) and Imaging application
• Customization of Remote Data Capture (RDC) Onsite Release 4.6 for Automation of read setup tasks
• Customization of Remote Data Capture (RDC) Onsite Release 4.6 for reader access security
• Oracle Clinical RDC Onsite 4.6 - upgrade from version 4.5.1 to v4.6
• Oracle Clinical Customized Audit Trail
• Clinical data assessment criteria for Radiology, Oncology and Overall Read Types: RECIST 1.0, RECIST 1.1, WHO, RANO, Cheson