Job Description

Roles & Responsibilities:

Lead and manage validation activities for LIMS and MES implementations, upgrades, and integrations. Develop and review Validation Master Plans (VMPs), Validation Protocols (IQ, OQ, PQ), and Test Scripts in compliance with GAMP 5 and company policies. Oversee validation deliverables across the System Development Life Cycle (SDLC) including User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and Traceability Matrices. Perform and document risk assessments, impact assessments, and change control validations for LIMS/MES systems. Ensure compliance with 21 CFR Part 11, EU Annex 11, GxP, and Data Integrity requirements. Collaborate with business users and technical teams to validate system configurations, interfaces, and data migration activities. Conduct periodic reviews, requalification, and system audit readiness for validated systems. Train and mentor validation engineers and coordinate validation activities with cross-functional project teams. * Support regulatory and internal audits by providing validation documentation and responses.