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CH12 Lonza AG
2mo ago

Senior QA Specialist, QA Project Management(m/w/x)

Visp
Full-timeOn-siteSenior

Description

In this role, you will play a crucial part in ensuring that API production meets GMP standards while collaborating with various teams. You will also serve as the quality liaison for clients, participating in audits and ensuring compliance throughout the manufacturing process.

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Requirements

  • •University degree in Life Sciences (Microbiology, Biotechnology, Chemistry)
  • •First experience in GMP environment, preferably in biopharmaceutical industry
  • •Strong communication skills and experience working with stakeholders from different departments
  • •Experience with TrackWise, SAP, LIMS, and DMS
  • •Batch release expertise
  • •Fluency in English and German (written and verbal)

Education

Bachelor's degree

Work Experience

approx. 4 - 6 years

Tasks

  • •Ensure API production complies with Good Manufacturing Practice (GMP)
  • •Support contract manufacturing processes
  • •Advise development, production, and analytical teams on GMP aspects
  • •Check manufacturing documentation for conformity
  • •Process change controls
  • •Review and approve deviations and out-of-specification (OOS) results
  • •Act as the quality contact for clients
  • •Present during GMP audits

Tools & Technologies

TrackWiseSAPLIMSDMS

Languages

English – Business Fluent

German – Business Fluent

Benefits

Bonuses & Incentives

  • •Compensation programs that recognize high performance

Startup Environment

  • •Agile career and dynamic working culture

Purpose-Driven Work

  • •Inclusive and ethical workplace
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