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LO
Lonza
yesterday

Senior QA Expert - Equipment Qualification & Validation(m/w/x)

Stein (AR)
Full-timeOn-siteSenior

Description

In this role, you will lead equipment validation for aseptic production lines, ensuring operational excellence and GMP compliance while driving high-impact projects in a cutting-edge environment.

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Requirements

  • Experience with aseptic fill&finish lines
  • Experience with equipment qualification and validation
  • Experience with health authority audits
  • Degree in life science or equivalent
  • Teamwork and positive culture contribution
  • Experience or interest in data integrity
  • Fluency in English and German skills

Education

Bachelor's degree

Work Experience

approx. 4 - 6 years

Tasks

  • Lead qualification and validation for aseptic fill and finish equipment
  • Manage GMP deviations within global quality management systems
  • Define qualification strategies for CAPEX and OPEX projects
  • Supervise equipment trending and sterilization process validation
  • Oversee change control management and CAPA handling
  • Serve as subject matter expert during audits and inspections
  • Manage the lifecycle of equipment qualification documentation
  • Approve SOPs, qualification protocols, and technical reports

Tools & Technologies

aseptic fill&finish linesGMPSwissmedicFDAdata integrity (DI)

Languages

EnglishBusiness Fluent

GermanBasic

Benefits

Bonuses & Incentives

  • Performance-based compensation programs

Corporate Discounts

  • Lifestyle benefits
  • Leisure benefits

Family Support

  • Family benefits

Other Benefits

  • Relocation assistance

Learning & Development

  • Agile career opportunities

Startup Environment

  • Dynamic work culture

Purpose-Driven Work

  • Inclusive and ethical workplace
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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