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.

- Robust 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.

📌 CSV SME (Bengaluru)
🏢 eMonkGlobal
📍 Bengaluru