Quality Assurance Manager

vor 1 Tag


St Gallen, Sankt Gallen, Schweiz SCHOTT AG Vollzeit

Welcome to SCHOTT Pharma

We are a leading international technology group with over 130 years of experience in specialty glass and glass-ceramics. Our portfolio includes high-quality products and intelligent solutions that serve various industries, including the pharmaceutical sector.

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Our Mission

  • To provide innovative solutions that improve human health and quality of life.

About the Job

We are seeking a highly skilled Validation Engineer to join our R&D and Global Engineering division. The successful candidate will be responsible for developing and implementing qualification and validation strategies for local and global projects.

Main Responsibilities

  • Developing qualification and validation strategies for local and global projects.
  • Consulting with the organization on qualification and validation matters.
  • Planning and executing qualification & validation activities, including project management and coordination.
  • Performing and moderating risk analysis according to specifications and standards.
  • Creating, reviewing, and updating qualification & validation documents.

Requirements

  • A university degree in engineering, computer science, life sciences, or a comparable field.
  • At least 3 years of practical work experience in qualification and/or validation in a regulated environment.
  • Solid knowledge of GMP, data integrity, GAMP, 21 CFR Part 11, EU-GMP Annex 11, and good documentation practice.
  • Good communication skills and intercultural openness.

Benefits

We offer a competitive compensation package and opportunities for professional growth and development.



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