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Validation Lead - RDT Pharma Technical Operations at Roche - ApplyBlast

Validation Lead - RDT Pharma Technical Operations

Roche

5 months ago

4.1 on Glassdoor

Petaling Jaya

Onsite

Full Time

Senior

0 applicants

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About this role

This Validation Lead role at Roche ensures GMP-critical digital systems for Pharma Technical Development meet the highest standards of quality and regulatory compliance. You will own the end-to-end Computer System Validation lifecycle, applying risk-based approaches to transition systems from PTD to RDT TechOps while maintaining audit readiness. As a subject matter expert, you will oversee testing strategies, manage change controls, and support deviations and CAPAs to safeguard patient safety and data integrity.

Responsibilities

Lead end-to-end Computer System Validation activities for GMP-critical systems
Apply risk-based validation strategies based on GxP classification
Manage change control processes to preserve validated system state
Support deviation investigations and corrective and preventive actions
Act as CSV subject matter expert during regulatory inspections

Skills

Qualifications

Bachelor's degree in Computer Science

About Roche

roche.com

Headquarters

Basel, Basel-Stadt, Switzerland

Company Size

10001+ employees

Founded

1896

View Profile

As a pioneer in healthcare, we have been committed to improving lives since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally.