Deviation Investigation Specialist 100%

Key Responsibilities

• Take ownership of deviation records from initiation through investigation to final closure
• Lead root cause investigations and document findings in compliance with internal quality standards
• Partner with Subject Matter Experts and relevant stakeholders to evaluate deviation impact on products and systems
• Apply structured investigational methodologies such as Fault Tree Analysis, Fishbone Diagram or Event and Causal Factor Analysis
• Define appropriate CAPAs and effectiveness checks to ensure sustainable resolution and prevent recurrence
• Maintain full compliance with cGMP requirements throughout the investigation lifecycle
• Ensure accurate documentation and timely completion of quality records
• Contribute to continuous improvement initiatives and support ongoing operational changes

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