Process Validation Expert
vor 2 Monaten
About the Role
We are seeking a highly skilled Qualification Expert to join our team at Roche's Kaiseraugst production center. As a key member of our Engineering Science and Technology (ES&T) department, you will play a critical role in ensuring the highest standards of pharmaceutical manufacturing and compliance with regulatory requirements.
Key Responsibilities
- Manage and execute qualification activities and small projects to maintain the qualified status of all assets over their entire lifecycle.
- Collaborate with Value Streams, ES&T Process Owners, and Quality Assurance to ensure seamless execution of qualification projects.
- Coordinate and monitor qualification projects, ensuring effective know-how transfer between projects and qualification tasks.
- 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.
- Ensure excellent communication with stakeholders, including Value Streams, ES&T, and other functions.
Requirements
- 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.
- Fundamental understanding of safety, quality systems, and quality assurance concepts, including current Good Manufacturing Practices (cGMPs).
- Excellent communication and influencing skills, with fluency in German and English.
- Specialized knowledge in qualification as a subject matter expert and good knowledge of relevant health authority requirements.
- Ability to perform at a high level in a constantly changing environment.
About You
We are looking for a positive-thinking, honest, and self-reflective individual with strong communication skills. You should have an open ear for the daily challenges of your colleagues and create a climate of mutual support. You should act as a team player, listen actively, and provide sufficient space for others to express their ideas.
What We Offer
As a Qualification Expert at Roche, you will have the opportunity to work in a dynamic and innovative environment, contributing to the development of high-quality medicines that improve people's lives. You will be part of a team that values collaboration, open communication, and continuous learning.
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