Validation Lead

The Validation Lead is responsible for overseeing and executing the validation of computerized systems, ensuring compliance with industry standards, regulatory requirements, and company policies. This role involves close collaboration with project teams, clients, and business analysts to develop, execute, and approve validation deliverables, especially within the pharmaceutical industry. Key Responsibilities Computerized System Validation (CSV): Lead all CSV tasks for assigned projects, ensuring thorough and compliant validation processes following GAMP 5, US FDA 21 CFR Part 11, and EU Annex 11 regulations. Develop validation documentation for pharmaceutical equipment, facilities, and computerized systems in GLP, GMP environments. Prepare and execute critical validation documents such as URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, and Traceability Matrix. Ensure that validation deliverables align with regulatory requirements and industry Oversee validation plans, specifications, test protocols, standard operating procedures (SOPs), and other related documentation for systems, including Enterprise IT applications. Provide a structured approach to the implementation of CSV Compliance & Regulatory Oversight: Ensure that validation efforts are in compliance with regulatory audits (e.g., US FDA, EMA) and industry standards. Proactively manage quality management system (QMS) tools and provide support during regulatory audits. Perform risk-based validation, reviewing and approving validation Experience in Agile environments, adapting validation processes Provide expertise in project management tools like Jira, ServiceNow, HP ALM, and other EDMS Client and Project Management Support: Work closely with clients and vendors to ensure that project deliverables meet quality Liaise between project tracks and client process owners, ensuring smooth project Minimum Education Qualification, Specialized Knowledge, and Skills: BE/B.Tech/MCA from a recognized university/institute. Minimum of 5 years of professional experience in CSV within the pharmaceutical Strong understanding of the validation lifecycle and experience leading validation Experience working in V model and SDLC life Technical Skills: Knowledge and experience with GAMP 5, US FDA 21 CFR Part 11, and related Experience in authoring and executing validation plans, traceability matrices, and summary Proficiency in QMS tools and exposure to regulatory Hands-on experience with Jira, ServiceNow, HP ALM, and EDMS Additional Skills: Excellent communication and interpersonal Ability to handle multiple projects and meet tight Strong problem-solving and organizational This remote Validation Lead role is pivotal in ensuring the quality and compliance of safety systems, contributing to the overall success of Sophos IT Services by adhering to stringent validation standards and regulatory requirements. Role: QA Team Manager Industry Type: Pharmaceutical & Life Sciences Department: Engineering - Software & QA Employment Type: Full Time, Permanent Role Category: Quality Assurance and Testing Education UG: B.Tech/B.E. in Any Specialization PG: MCA in Computers Key Skills IT servicesComplianceEDMSProject managementQMSStandard operating proceduresGLPGMPRisk managementSDLC