Senior Deviation Specialist

Senior Deviation Specialist

Lonza

Visp, Switzerland

Currently we are looking for Senior Deviation Specialist who will own Major and Minor deviations and ensure they are completed with the expected level of Quality and accuracy and within the expected timelines.

Key responsibilities:

• Own, investigate, author, and record assigned Deviations.
• Liaise with Subject Matter Experts (SMEs) and key stakeholders to establish the root cause(s) of deviations and the potential impact of said deviations.
• Ensure proper investigation tools are used to systematically define all root causes and contributing factors (e.g. Logic Fault Tree, Defense analysis, Event & Causal Factors chart, Fishbone)
• Define and agree with SMEs appropriate CAPA(s), and associated Effectiveness Checks.
• Ensure cGMP compliance and consistency through the investigation process and drive their quality records to completion and closure according to scheduled release times.
• Support the business through ongoing change and process improvement activities.
• Perform other duties as assigned.

Key requirements:

• Bachelor degree/Diploma in a Chemistry/Biotechnology/Life sciences or related discipline.
• Ability to plot and read data, statistics basic knowledge is a nice to have.
• Understanding and application of Human & Organizational Performance principles.
• RCA training.
• Analytical thinking and problem solving skills.
• High adaptability in dynamic work environments.
• Effective and efficient time management.
• Skillful knowledge of Microsoft Windows and Microsoft Office (Excel, Word, Project, PowerPoint).
• Fluency in English.