CSV SME

Responsibilities

• Serve as an SME in CSV processes and best practices
• Develop and execute validation protocols (IQ/OQ/PQ) for computer systems, software applications, and automated processes.
• Create validation plans, test scripts, and summary reports.
• Ensure all computer systems comply with FDA regulations, GxP guidelines, and other relevant industry standards (e.g., 21 CFR Part 11).
• Provide training to staff on CSV processes and regulatory requirements
• Stay updated on industry best practices, regulatory changes, and advancements in technology related to CSV.
• Identify opportunities for improving validation processes and procedures.
• Perform Change Impact Assessments, Risk Assessments, Periodic Reviews .

NOTE: Experience in IT Systems Validation is a must. Specifically experience with LMS(Learning Management System) is must.

Preferred candidate profile

• 5-6 years of overall experience in computer system validation within the pharmaceutical, biotech, or medical device industry.
• Experience with validation of IT Systems(LMS).
• Knowledge in process required for GxP and Non-GxP systems/features.
• Strong knowledge of FDA regulations, GxP guidelines, and industry standards (e.g., 21 CFR Part 11, GAMP 5).
• Experience working with cross function teams.
• Proficiency in developing and executing validation protocols and related documentation.
• Proficient in using validation tools and software.
• Strong written and verbal communication skills.

Education and Trainings

• Bachelors degree in Biotechnology, Pharmacy, Computer Science, Engineering, Life Sciences, or a related field.
• Advanced degrees or certifications in validation, quality assurance, or regulatory compliance are a plus.