Beschreibung
Qualification Expert (m/f/d)
Reference: -en
Start: asap
Duration: unbefristet
Main tasks:
- As Qualification/Validation Expert, you manage and execute qualification/validation activities and small projects and ensure maintaining the qualified status of all assets over their entire lifecycle
- 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
- You have ownership and perform execution of qualification/validation changes (PE, CAPA) and deviations (UPE, Investigations)
- Qualification/Validation Impact Assessments and supporting troubleshooting is part of your daily business
- You support review activities during the lifecycle
Main qualifications
- University degree in Process / chemical engineering, biotechnology, chemistry, mechanical engineering and proven professional experience in pharmaceutical production, qualification, engineering or validation
- You have knowledge of production processes, pharmaceutical or process engineering (e.g. 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/validation 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
Main advantages:
- Fascinating, innovative environment in an international atmosphere
About us:
Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience. As your professional companion, we support you throughout the entire process, from the first contact to the first day on your new job – all this completely free of charge. Register now and look forward to many interesting and suitable positions and projects.
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