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Senior Deviation Specialist (80%-100%)

lonza · Visp

New
Senior 🇬🇧 English
GMP CAPA Root cause analysis 5 Whys Fishbone diagram FMEA TrackWise Veeva FDA EMA ICH

Job description

About the role

Lonza's Quality organization in Visp, Switzerland is looking for a Senior Deviation Specialist for a fully site-based role. You will lead complex investigations, drive continuous improvement and collaborate across functions to keep the highest GMP standards, helping ensure the quality, compliance and reliability of life-saving therapies.

Key responsibilities

  • Lead complex GMP deviation investigations using structured root cause analysis methods to find underlying issues and implement sustainable solutions.
  • Work closely with Manufacturing, Quality Control, Engineering and other stakeholders to gather data, evaluate findings and drive effective CAPAs.
  • Write clear, scientifically sound and compliant deviation reports in line with internal procedures and global regulatory expectations.
  • Monitor CAPA implementation and effectiveness, ensuring timely completion and reducing the risk of recurring deviations.
  • Act as a subject matter expert during internal and external audits, supporting inspection readiness and defending investigation outcomes.
  • Analyze deviation trends, identify improvement opportunities and contribute to initiatives that strengthen process reliability and product quality.
  • Take part in risk assessments and change control activities to prevent quality issues and support continuous improvement.

Required profile

  • Several years of experience in a GMP-regulated pharmaceutical, biotechnology or medical device environment, focused on quality systems, deviation management, QA or QC.
  • Degree in a scientific or engineering discipline, or equivalent experience.
  • Strong understanding of cGMP requirements and global regulatory expectations, including FDA, EMA and ICH guidelines.
  • Excellent written and verbal communication in German and English.

Required skills

  • Root cause analysis methods such as 5 Whys, Fishbone Diagrams, FMEA or similar structured problem-solving approaches.
  • Quality management systems such as TrackWise, Veeva or comparable platforms.
  • Ability to interpret data, assess risks and make sound quality decisions in a fast-paced manufacturing environment.

What we offer

  • An agile career and dynamic working culture.
  • An inclusive and ethical workplace.
  • Compensation programs that recognize high performance.
  • A variety of benefits depending on role and location.

Questions fréquentes

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Source : ats:workday

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Published 2 hours ago

Expires 1 month from now

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lonza

Visp