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Lonza
21h ago

Senior QA Expert – Critical Utilities & Facilities(m/w/x)

Stein (AR)
Full-timeOn-siteSenior

Description

You will lead the qualification of critical utilities for sterile manufacturing, ensuring GMP compliance across high-impact projects while acting as a key expert during audits and inspections.

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Requirements

  • Experience in qualification and validation
  • Experience with health authority audits
  • Knowledge of GMP regulatory guidelines
  • Degree in life science or equivalent
  • Teamwork and support of colleagues
  • Fluency in English and German skills

Education

Bachelor's degree

Work Experience

approx. 4 - 6 years

Tasks

  • Lead qualification and validation for infrastructure and utilities
  • Manage GMP deviations within global QMS systems
  • Define qualification strategies for CAPEX and OPEX projects
  • Supervise change control, deviations, and CAPA handling
  • Monitor GMP status and trending for re-qualification
  • Serve as SME during audits and inspections
  • Approve SOPs, qualification protocols, and reports
  • Oversee lifecycle management for qualification documents

Tools & Technologies

GMP Annex 1GMP Annex 11GMP Annex 15HVAC

Languages

EnglishBusiness Fluent

GermanBasic

Benefits

Bonuses & Incentives

  • Performance-based compensation programs

Corporate Discounts

  • Lifestyle benefits
  • Leisure benefits

Family Support

  • Family benefits

Career Advancement

  • Agile career

Startup Environment

  • Dynamic work culture

Purpose-Driven Work

  • Inclusive and ethical workplace

Other Benefits

  • Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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