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LO
Lonza
11d ago

Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(m/w/x)

Visp
Full-timeOn-siteSenior

Description

In this role, you will ensure facility and equipment compliance with cGMP standards while acting as a key quality representative in technical projects to drive continuous improvement and audit readiness.

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Requirements

  • Degree in Biotechnology, Pharmacy, Microbiology, Chemistry, Engineering or related field
  • Significant experience in biopharmaceutical manufacturing and cGMP background
  • Broad knowledge of engineering and manufacturing processes
  • Good communication and interaction skills with organizational interfaces
  • Sound experience representing Quality and Compliance in projects
  • Strong team orientation
  • Fluency in English, German would be an asset

Education

Bachelor's degree

Tasks

  • Ensure facility and equipment qualification complies with cGMP
  • Represent Quality and Compliance in cross-functional project teams
  • Oversee qualification and routine monitoring of utilities
  • Coordinate quality objectives across various project phases
  • Identify and integrate emerging QA technologies into standards
  • Review and approve qualification plans and reports
  • Assess technical change requests for qualification relevance
  • Document and investigate project deviations and issues
  • Drive CAPA and effectiveness checks to timely completion
  • Represent environmental monitoring topics during audits and inspections
  • Write and revise SOPs as a subject matter expert

Tools & Technologies

cGMP

Languages

EnglishBusiness Fluent

GermanBasic

Benefits

Bonuses & Incentives

  • Performance-based compensation programs

Family Support

  • Lifestyle, family, and leisure benefits

Career Advancement

  • Agile career

Informal Culture

  • 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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