Validation Lead

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

• 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

• Work closely with clients and vendors to ensure that project deliverables meet quality
• Liaise between project tracks and client process owners, ensuring smooth project

• 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

• 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