Job
Description
Role & responsibilities To lead and manage the Computer System Validation (CSV) activities for our injectable manufacturing operations. The candidate need to ensure compliance with regulatory requirements (e.g., US FDA 21 CFR Part 11, EU Annex 11, GAMP 5) and internal quality standards for all GxP-relevant computerized systems used across production, quality control, and laboratory environments. Lead and oversee all CSV activities for GxP-critical systems (LIMS, ERP, MES, SCADA, PLCs, EMS, BMS, etc.) in the injectable manufacturing setup. Develop and maintain validation master plans (VMPs), risk assessments, validation protocols (IQ/OQ/PQ), and reports in line with regulatory expectations and industry best practices. Ensure validation lifecycle management, including periodic review, re-validation, and change control assessments. Collaborate with IT, Quality, Engineering, Production, and external vendors to ensure smooth implementation and validation of new computerized systems or upgrades. Drive data integrity initiatives and compliance across computerized systems and related workflows. Conduct internal audits, gap assessments, and readiness checks for regulatory inspections related to CSV. Provide training and guidance to cross-functional teams on CSV policies, procedures, and regulatory updates. Track regulatory developments and industry trends to continuously improve CSV and data integrity frameworks Preferred candidate profile B.E./B.Tech or a Masters in Pharmacy with 12 - 16 years of experience in Computer System Validation within regulated pharmaceutical manufacturing, preferably injectable / sterile dosage forms. Strong understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity guidelines. Hands-on experience with LIMS, ERP, SCADA, BMS/EMS, and electronic batch records. Experience in handling regulatory inspections (e.g., USFDA, MHRA, EU, WHO) from a CSV perspective
