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Lonza
22d ago

QA Expert - Equipment Qualification & Validation and Data Integrity(m/w/x)

Stein (AR)
Full-timeOn-siteExperienced

Description

In this role, you will oversee the qualification and validation of cutting-edge equipment while supporting data integrity initiatives. Your day-to-day responsibilities will involve ensuring compliance with GMP standards and leading efforts to enhance operational readiness in a dynamic pharmaceutical environment.

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Requirements

  • •Solid experience with aseptic fill&finish lines in a GMP environment
  • •Solid experience with qualification and validation of production equipment
  • •Experience with health authorities audit and customer inspections
  • •Degree in life science or equivalent experience
  • •Value teamwork and positive work culture
  • •Experience or interest in data integrity topics
  • •Fluency in English; German language skills advantageous

Education

Bachelor's degree

Work Experience

approx. 1 - 4 years

Tasks

  • •Lead qualification and validation activities for equipment and infrastructure
  • •Support data integrity activities, including attending deviation review boards
  • •Prepare site data integrity assessments and reports
  • •Host site data integrity meetings
  • •Co-lead the site data integrity program
  • •Act as a contact person for GMP-related issues and deviations
  • •Ensure adherence to qualification strategies during CAPEX and OPEX projects
  • •Supervise GMP status and trending of equipment
  • •Manage (re-)qualification and (re-)validation of production equipment
  • •Ensure compliance with change control management and CAPA handling
  • •Serve as a subject matter expert during audits and inspections
  • •Oversee life cycle management of qualification documents, including SOPs and protocols

Languages

English – Native

German – Basic

Benefits

Corporate Discounts

  • •Lifestyle benefits
  • •Leisure benefits

Family Support

  • •Family benefits

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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