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LOLonza

Head of QA Support (Shop Floor and Batch Record Review)(m/w/x)

Visp
Full-timeOn-siteManagement

Oversight of QA Documentation and Shop Floor teams, reviewing Aseptic Processing Simulations for Drug Product manufacturing at a global biopharmaceutical manufacturer. Extensive Drug Product QA and people leadership experience essential. Leading QA teams across multiple global manufacturing sites.

Requirements

  • University degree in Chemistry, Biology, Biotechnology, or related field
  • Experience in people leadership and strategic roles
  • Valuable experience in QA department specifically Drug Product
  • Fluent English language skills
  • Advantageous German language skills

Tasks

  • Oversee the QA Documentation and Shop Floor teams
  • Implement and execute the QA Oversight program
  • Monitor routine manufacturing and testing activities
  • Review and approve Aseptic Processing Simulations
  • Develop APS strategies, annual plans, and protocols
  • Perform batch record reviews for paper and MES
  • Represent QA during MES implementation projects
  • Manage the archiving of paper and digital documents
  • Lead Deviation Review Board meetings
  • Provide GXP-related training to operations personnel
  • Author and approve GMP-relevant documents and SOPs
  • Support continuous improvement of the Quality Management System
  • Prepare batch release documentation for the responsible person
  • Coordinate with customers regarding QA operations topics

Work Experience

  • approx. 1 - 4 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent
  • GermanBasic

Benefits

Bonuses & Incentives

  • Performance-based compensation programs

Corporate Discounts

  • Lifestyle benefits
  • Leisure benefits

Family Support

  • Family benefits

Career Advancement

  • Agile career

Informal Culture

  • Dynamic work culture

Purpose-Driven Work

  • Inclusive and ethical workplace
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