Validation Lead - RDT Engineering Excellence & Experience - roche

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The Position

Job description

At Roche, compliance is our license to operate, and we are committed to delivering high-quality products. Every contribution you make will impact patients, as patient safety is at the forefront of everything we do. As a Senior IT Validation Professional, you will play a pivotal role in ensuring the quality of the products we deliver. You will be responsible for the evaluation, design, development, and approval of qualification deliverables, validation plans, protocols, and reports for computerized systems across various domains and product lines.

Description of the area

The specific computerized systems related to this role are general purpose platforms for automation and application development. These platforms are used across Roche for a variety of GxP and non-GxP purposes.

Job Responsibilities

Validation / Qualification Strategy: Determine validation approaches and identify deliverables needed or impacted by projects, enhancements, or changes for GxP computerized systems.

Documentation Review and Development: Review system documentation in accordance with Roche CSV SOPs and regulatory guidance. Develop and approve validation plans and reports; develop and approve qualification plans and reports; review and authorize test plans and reports, ensuring the system is ready to go live.

Testing and Consultancy: Verify testing plans, activities, deliverables, and records. Provide consultancy on test-related deviations and corrective actions as per approved procedures.

Deviation and Root Cause Analysis: Support investigations into deviations, identifying root causes, and defining corrective and preventive actions.

Audit and Inspection Preparation: Act as a subject matter expert in CSV for system audit/inspection preparation and execution.

System Maintenance: Ensure the validated state of systems is maintained, keeping them audit and inspection ready.

Periodic Reviews: Lead and support system periodic reviews in accordance with company procedures.

Continuous Improvement: Implement relevant frameworks and processes, propose and utilize tools, and prepare recommendations for process optimization.

Training and Knowledge Sharing: Provide training and exchange validation/quality knowledge and experience.

Qualifications

Education: Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.