Job Description

Provide IT support to QC, Production, AD, and Engineering departments for daily operations, audits, and validations. Coordinate and support CSV (Computer System Validation) activities for software, lab instruments, and manufacturing systems. Administer and manage Active Directory, user access controls, system privileges, and security as per IT GMP requirements. Support and manage IT infrastructure and applications in controlled environments including LIMS, CDS, EMS, BMS, SCADA, and MES. Prepare and maintain documentation like IQ/OQ/PQ protocols, SOPs, Risk Assessments, and Audit Trails. Liaise with QA and regulatory teams to ensure compliance with 21 CFR Part 11, GAMP, EU Annex 11, and Data Integrity requirements. Monitor and maintain backup, disaster recovery plans, and data archival systems for critical GMP systems. Provide first-level ERP support including user access, basic troubleshooting, and coordination with functional/technical teams for escalations.