Pharmaceutical Qualification Expert with Innovative Spirit
vor 2 Wochen
The Roche production center in Kaiseraugst is a hub of innovation and excellence, where our employees work together to ensure uninterrupted patient care through high-quality medicines.
We are seeking a skilled Pharmaceutical Qualification Expert to join our team and contribute to the success of our site. As a key member of our ES&T department, you will play a critical role in advancing and enabling innovation and improvement by using science, technical knowledge, and predictive services.
As a Pharmaceutical Qualification Expert, your primary responsibility will be to manage and execute PTM qualification activities and small projects, ensuring that all assets remain qualified over their entire lifecycle. Your area of responsibilities will include:
- Maintaining the qualified status of all assets in close collaboration with Value Streams, ES&T Process Owners, and Quality Assurance.
- Coordinating and monitoring qualification projects to ensure know-how transfer between individual projects and qualification tasks, promoting systemic learning and continuous improvement of the qualification process.
- Initiating and executing qualification risk assessments, authoring qualification documentation (URS, QMP, QPPs, QSR, test protocols, SOPs, rationales, etc.), and reviewing technical documentation.
- Presenting qualification plans, reports, and status (including preparation, presentation, support, and follow-up) during health authority inspections and audits.
- Fostering excellent information flow with stakeholders from Value Streams, ES&T, PLANTS, PS, PTQ, PTT, PTM, PTD, other functions, suppliers, and more.
In addition, you will have ownership and perform execution of qualification changes (PE, CAPA) and deviations (UPE, Investigations), as well as Qualification Impact Assessments and supporting troubleshooting. You will also support qualification review activities throughout the lifecycle.
We are looking for a positive-thinking, honest, and self-reflective personality with strong communication skills. As a team player, you should be able to actively listen, provide space for others to express their ideas, and speak openly and honestly on controversial issues.
To succeed in this role, you should possess:
- 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 and in-depth understanding of production processes, pharmaceutical or process engineering filling techniques, lyophilization, filtration, and/or packaging technology.
- Fundamental working understanding of safety, quality systems, and quality assurance concepts, including application of current Good Manufacturing Practices (cGMPs).
- Ability to effectively communicate and influence others across all levels of the organization with fluent verbal and written communication skills in German and English.
- Specialized knowledge in the area of qualification as a subject matter expert and good knowledge of relevant health authority requirements.
- Ability to consistently perform at a high level in a constantly changing environment.
You should have a proven track record of successful project delivery, expertise in stakeholder management, and ability to reduce complexity. Experience in dealing with digitization of processes (Valgenesis, etc.) is ideal.
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