Job Summary:
We are seeking a Computer System Validation (CSV) Engineer with 1–2 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in Computer System Validation (CSV), a strong understanding of GxP and 21 CFR Part 11, and experience with IQ/OQ/PQ documentation and execution. The role involves ensuring computerized systems comply with regulatory requirements through validation activities, documentation, risk assessments, and cross-functional collaboration.
Experience: 1–2 Years
Location: Mahape Navi Mumbai
Notice Period: Immediate / 15 Days Preferred
Job Requirements:
Experience in Pharma domain
Knowledge of GxP, 21 CFR Part 11
Experience in Computer System Validation (CSV)
Knowledge of IQ, OQ, PQ documentation
Good communication skills
Key Responsibilities:
● Review new system requirements.
● Prepare validation documents.
● Conduct risk assessments.
● Execute IQ/OQ/PQ protocols.
● Coordinate with IT, Quality Assurance (QA), Engineering, and vendors.
● Review deviations and change requests.
● Maintain validation records.
● Support audits and regulatory inspections.
● Ensure ongoing compliance with applicable regulatory requirements.
Pay: ₹20,000.00 - ₹25,000.00 per month
Work Location: In person
