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LOLonza

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

Stein (AR)
Full-timeOn-siteSenior

Leading qualification and validation for critical utilities and facilities at a global life sciences manufacturer, managing GMP deviations. Experience with health authority audits and GMP regulatory guidelines essential. Global project scope, hybrid work model.

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

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

Work Experience

  • approx. 4 - 6 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent
  • GermanBasic

Tools & Technologies

  • GMP Annex 1
  • GMP Annex 11
  • GMP Annex 15
  • HVAC

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
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