- Design, develop, test, and maintain CSV (Computer System Validation) protocols for pharmaceutical equipment and systems.
- Collaborate with cross-functional teams to ensure compliance with GAMP (Good Automated Manufacturing Practice) guidelines.
- Conduct deviation investigations and implement corrective actions to maintain data integrity.
- Develop IQ/OQ/PQ documents for new equipment installations or modifications.
Job Requirements :
- 5-10 years of experience in CSV engineering in the pharmaceutical industry.
- Robust understanding of computer system validation principles and regulations (e.g., FDA 21 CFR Part 11).
- Experience with GXP (Good X Practices) development and implementation.
- Proficiency in creating IQ/OQ/PQ documents using standard templates.
📌 CSV Engineer (Pune)
🏢 R Systems International
📍 Pune
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