Urgent requirement for CSV department at Natco Pharma Ltd
Department : IT – CSV
Qualification : B Tech
Experience : 5 to 7 years
Work Location : Kothur
· Experience in Pharmaceutical Industry CSV role
· Should have experience in implementation of Lab & QMS Applications like LIMS, Empower, QMS, LMS, eLogbook, TrackWise, SAP etc.
· Experience in GAP Analysis and documenting Remediation Plan
· Experience in Preparation of Risk Assessments
· Experience in Creating Protocols, Test Scripts e.g., IQ, OQ, PQ etc.
· Experience in generating and reviewing Computer Systems Validations CSV Deliverables according to GAMP5 and 21 CFR Part 11 and FDA regulations.
· Capability to quickly gain a detailed understanding of process and generating validation documents.
· Experience in Conducting Training to the CFT(s) on 21 CFR Part-11 Validation, EU GMP Annex11 Assessments, SOPs etc.
· Aware of IT systems and QMS practices
Interested & relevant experienced candidates can share CV’s to Jaganmohan.email@example.com