- You ensure maintaining the qualified status of all assets over their entire lifecycle in close collaboration with Value Streams and ES&T Process Owners and Quality Assurance
- You coordinate and monitor qualification projects and ensure the know-how transfer between the individual projects and qualification tasks enabling systemic learning and continuous improvement of the qualification process.
- You initiate and execute qualification risk assessments, author qualification documentation (URS, QMP, QPPs, QSR, test protocols, SOPs, rationales etc) and review technical documentation
- In health authority inspections and audits you present qualification plans, reports and status (including preparation, presentation, support, and follow-up)
- Ensuring an excellent flow of information with all stakeholders Value streams, ES&T, PLaNTs, PS, PTQ, PTT, PTM, PTD, other functions, suppliers etc.)
- A master degree in Process / chemical engineering, biotechnology, chemistry, mechanical engineering and minimum 3 years of professional experience in pharmaceutical production, qualification, engineering or validation
- You have deep knowledge and in-depth knowledge of production processes, pharmaceutical or process engineering filling techniques, lyophilization, filtration) and/or packaging technology
- A fundamental, working understanding of safety, quality systems, and quality assurance concepts are required including the application of current Good Manufacturing Practices (cGMPs)
- You have the 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.
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Qualification Expert, Kaiseraugst - Roche
Beschreibung
The Position
With its 1,400 employees, the Kaiseraugst production center (PT Manufacturing) ensures uninterrupted patient care with high-quality medicines. We stand for the highest standards of pharmaceutical manufacturing, Roche's largest, most innovative packaging center and serving more than 120 countries.
For a successful production site Kaiseraugst Engineering Science and Technology ( ES&T) advances and enables innovation and improvement by using science, technical knowledge and predictive services. Our key success factors for sustainable and compliant asset performance are continuous improvement of our processes, agile employees and passion
As Qualification Expert, you manage and execute PTM Kau qualification activities and small projects and ensure maintaining the qualified status of all assets over their entire lifecycle.
Your area of responsibilities as Qualification Expert:
Furthermore you have ownership and perform execution of qualification changes (PE, CAPA) and deviations (UPE, Investigations) as well as Qualification Impact Assessments and supporting troubleshooting is part of your daily business. You support qualification review activities during the lifecycle.
Who you are
You are a positive-thinking, honest and self-reflective personality with strong communication skills. You have an open ear for the daily challenges of your colleagues and create a climate of mutual support. You act as a team player, listen actively and provide sufficient space for others to express their ideas. You ask questions to understand, speak openly and honestly on controversial issues.
Your Qualifications/Requirements:
Furthermore you have proven successful delivery of projects and expertise in stakeholder management and ability to reduce complexity. You have a track record of having the courage to drive change, while balancing risks and pacing for success with the ability and openness to recognize and live the opportunities and advantages of change. Ideally you bring experience in dealing with digitization of processes (Valgenesis, etc)
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