Computer System Validation

SOHAIL SHARIF

Phone: 510-***-**** Email: ***************@*****.***

Professional Summary

●Over 6+ years of experience in Computer System Validation (CSV), Commissioning, Qualification & Validation (CQV), and Shipping/Transport Validation in the pharmaceutical/biopharmaceutical industry.

●Specialized in transport qualification strategies, shipping validation, and program leadership, ensuring compliance with FDA, EMA, GAMP 5, and cGMP regulations.

●Strong expertise in documenting and reviewing validation deliverables (URS, FRS, DS, IQ, OQ, PQ, VMP, RTM, VSR), establishing testing and validation protocols, and ensuring timely project delivery.

●Superior knowledge of GxP regulations (GLP, GMP, GCP), 21 CFR Part 11 (ERES, Audit Trails), and global compliance standards.

●Proven ability to track project status, report validation progress to leadership, and lead cross-functional teams to meet quality and regulatory objectives.

●Skilled in root cause analysis, CAPA management, change control, and supporting regulatory inspections and audits.

Technical Skills

●Validation: Shipping/Transport Validation, CQV, CSV, IQ/OQ/PQ, SOPs, Gap Analysis, RTM, Audit Trails, Remediation Plans

●Compliance: 21 CFR Part 11 (210, 211, 50), cGxP (GLP, GMP, GCP), FDA/EMA Regulations, GAMP 5

● SDLC Methodologies: Agile, Waterfall, Spiral, V-Model

● Applications: LIMS, ERP, AERS, ARGUS, ArisG, QMS, LMS

●Tools: HP ALM, HP Quality Center, TrackWise, SAP, JIRA, MS Project

●Operating Systems & Servers: Windows Server 2008R2/12 R2, Windows 7/8/10

Professional Experience

Client: Lonza, TX

Role: Computer System Validation Engineer

May 2024 – Present

●Led shipping validation and transport qualification projects, including lane mapping, thermal package qualification, and stability studies in compliance with GDP and cGMP.

●Designed and reviewed transport qualification strategies and ensured on-time delivery of milestones across multiple projects.

●Tracked validation program progress and provided periodic status reports to leadership for decision-making and compliance visibility.

●Documented URS, IQ, OQ, PQ, and Validation Plans for data solutions, infrastructure qualification, and lab equipment.

●Authored SOPs, manuals, and protocols for CSV, analytical instruments, spreadsheets, and SAP-based systems.

●Reviewed and approved Requirements Specifications, Functional Specifications, Test Plans, Qualification Protocols, and Final Reports.

●Supported risk assessments, deviation management, and CAPA investigations to ensure compliance and continuous improvement.

Client: Formonex Solutions, HYD

Role: Computer System Validation Analyst

Jan 2020 – Nov 2022

●Reviewed and approved Change Requests ensuring completeness, compliance, and documentation quality.

●Assessed quality, compliance, and business impact of changes, prioritizing based on risk.

●Drafted Test Plans, Implementation Plans, and Recovery/Back-out Plans for regulated applications.

●Collaborated with cross-functional teams (Development, Compliance, Change Management) to move fixes and patches across environments.

●Supported root cause analysis for issues and contributed to CAPA planning to minimize future risks.

●Mentored junior validation staff and supported training programs on CSV processes.

Client: Reddy Labs, India

Role: Computer System Validation Specialist

May 2017 – Dec 2019

●Coordinated with Regulatory Operations and IT to execute Validated System Change Requests (VSCRs) for Insight Publisher upgrades.

●Drafted and executed IQP, OQP, and validation deliverables, ensuring compliance with FDA standards.

●Managed change control, deviation tracking, and CAPA initiation within TrackWise and SharePoint.

●Conducted audit trail reviews, time stamp, and electronic signature validation for compliance with 21 CFR Part 11.

●Performed gap analysis of QMS, executed migration activities, and provided end-to-end document control support.

Education:

• Masters in Information Technology and Management from Indiana Wesleyan University - Jan 2023-2024 Dec

• Bachelor in Business Administration from St. Paul’s degree college - 2017

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