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Lonza
12d ago

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

Visp
Full-timeOn-siteManagement

Description

You will lead the QA oversight and documentation teams to ensure manufacturing excellence. By managing batch releases and APS strategies, you will play a vital role in maintaining high GXP standards.

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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

Education

Bachelor's degree

Work Experience

approx. 1 - 4 years

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

Languages

English – Business Fluent

German – Basic

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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