Qualification Expert

Vor 6 Tagen

Kaiseraugst, Aargau, Schweiz Roche Vollzeit

The Role

At Roche, we are committed to delivering high-quality medicines to patients worldwide. As a Qualification Expert, you will play a critical role in ensuring the uninterrupted supply of these medicines by managing and executing qualification activities and projects in our Kaiseraugst production center.

Your Responsibilities

  • Sustain the qualified status of all assets over their entire lifecycle in close collaboration with Value Streams, ES&T Process Owners, and Quality Assurance.
  • Coordinate and monitor qualification projects, ensuring the know-how transfer between individual projects and qualification tasks to facilitate systemic learning and continuous improvement of the qualification process.
  • Initiate and execute qualification risk assessments, author qualification documentation, and review technical documentation.
  • Present qualification plans, reports, and status during health authority inspections and audits, preparing, presenting, supporting, and following up as needed.
  • Ensure an excellent flow of information with stakeholders, including Value Streams, ES&T, PLANTS, Quality Assurance, and other functions, suppliers, etc.

Your Profile

We are looking for a positive-thinking, honest, and self-reflective individual with strong communication skills. You will have an open ear for your colleagues' daily challenges and create a climate of mutual support. As a team player, you will listen actively and provide sufficient space for others to express their ideas. You will ask questions to understand, speak openly and honestly on controversial issues, and have a fundamental understanding of safety, quality systems, and quality assurance concepts, including current Good Manufacturing Practices (cGMPs).

Your Qualifications

  • A master's degree in Process/Chemical Engineering, Biotechnology, Chemistry, or Mechanical Engineering, with a minimum of 3 years of professional experience in pharmaceutical production, qualification, engineering, or validation.
  • Deep knowledge of production processes, pharmaceutical or process engineering filling techniques, lyophilization, filtration, and/or packaging technology.
  • A working understanding of safety, quality systems, and quality assurance concepts, including cGMPs.
  • Excellent verbal and written communication skills in German and English, with the ability to effectively communicate and influence others across all levels of the organization.
  • Specialized knowledge in the area of qualification as a subject matter expert and good knowledge of relevant health authority requirements.
  • The ability to consistently perform at a high level in a constantly changing environment.

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