Novartis Pharma AG
Qualified Person Radiopharmaceuticals(m/w/x)
Full-timeOn-siteNot specified
Nürnberg
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NONovartis Pharma AG
Qualified Person Radiopharmaceuticals(m/w/x)
Nürnberg
Full-timeOn-site
Nejo AI Summary
Certifying and releasing batches of investigational medicinal products, ensuring compliance with German Drug Law. QP qualification per AMG §15, specifically for radiopharmaceuticals, required. Work environment focused on innovative patient care solutions.
Requirements
- Qualification as a Qualified Person according to AMG §15
- Qualification as a Qualified Person for radiopharmaceuticals according to AMG §15 (3a) 5
- Profound knowledge of pharmaceutical regulations
- Proactive and self-initiated work style with high sense of responsibility
- Analytical thinking and flexible, solution-oriented work style
- Strong organisational and persuasional skills
Tasks
- Certify and release batches of investigational medicinal products (IMPs)
- Certify and release batches of radiopharmaceutical IMPs
- Review and approve quality-relevant documentation for batch release
- Ensure compliance with local and international regulations, especially German Drug Law
- Continuously improve the quality assurance system and processes
- Systematically enhance compliance and operational levels
- Manage corrective and preventive actions (CAPA)
- Assist in handling complaints
- Oversee change control management
- Prepare and review standard operating procedures (SOPs)
- Manage projects independently
- Collaborate actively on quality-related projects across teams
- Train interns and student apprentices
Education
- Master's degree
Languages
- German – Native
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharma AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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NONovartis Pharma AG
Qualified Person Radiopharmaceuticals(m/w/x)
Nürnberg
Full-timeOn-site
Nejo AI Summary
Certifying and releasing batches of investigational medicinal products, ensuring compliance with German Drug Law. QP qualification per AMG §15, specifically for radiopharmaceuticals, required. Work environment focused on innovative patient care solutions.
Requirements
- Qualification as a Qualified Person according to AMG §15
- Qualification as a Qualified Person for radiopharmaceuticals according to AMG §15 (3a) 5
- Profound knowledge of pharmaceutical regulations
- Proactive and self-initiated work style with high sense of responsibility
- Analytical thinking and flexible, solution-oriented work style
- Strong organisational and persuasional skills
Tasks
- Certify and release batches of investigational medicinal products (IMPs)
- Certify and release batches of radiopharmaceutical IMPs
- Review and approve quality-relevant documentation for batch release
- Ensure compliance with local and international regulations, especially German Drug Law
- Continuously improve the quality assurance system and processes
- Systematically enhance compliance and operational levels
- Manage corrective and preventive actions (CAPA)
- Assist in handling complaints
- Oversee change control management
- Prepare and review standard operating procedures (SOPs)
- Manage projects independently
- Collaborate actively on quality-related projects across teams
- Train interns and student apprentices
Education
- Master's degree
Languages
- German – Native
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharma AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Novartis Pharma AG
Industry
Pharmaceuticals
Description
Das Unternehmen setzt sich für Vielfalt, Chancengleichheit und Inklusion ein und fördert innovative Lösungen zur Verbesserung der Patientenversorgung.
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