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Validation Lead - RDT Pharma Technical Operations

F. Hoffmann-La Roche AG
Location 📍 petaling jaya, Malaysia
Posted 📅 June 07, 2026
Work Type ⏰ Full-time

Position Overview

Position

As a Validation Lead within RDT Pharma Medicines TechOps, you will play a critical role in ensuring that the digital systems supporting Pharma Technical Development (PTD) meet the highest standards of quality, regulatory compliance, and patient safety. You will be the validation subject matter expert across a portfolio of GMP‑critical systems transitioning from PTD to RDT TechOps – owning the end‑to‑end validation lifecycle and ensuring our systems remain audit‑ready, compliant, and fit for purpose. Your work will directly support the integrity of processes that bring medicines to patients around the world.

Responsibilities

  • Lead the end‑to‑end Computer System Validation (CSV) and Computer System Assurance (CSA) activities for GMP‑critical PTD systems, including validation planning, protocol development, execution oversight, and report approval – ensuring systems are validated, maintained, and audit‑ready throughout their lifecycle.
  • ...

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Job Details

Employment Type
Full-time
📊
Category
Management & Operations
🏠
Work Arrangement
On-site
📍
Location
petaling jaya, Malaysia