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Qualified Person Radiopharmaceuticals(m/w/x)
Certifying and releasing radiopharmaceutical investigational medicinal product batches at a drug discovery firm. QP qualification for radiopharmaceuticals per AMG §15 (3a) 5 required. Work with AI-powered drug discovery tools.
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 investigational medicinal products (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
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Not a perfect match?
- Novartis Pharma AGFull-timeOn-siteNot specifiedNürnberg
- CSL Plasma
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Qualified Person Radiopharmaceuticals(m/w/x)
Certifying and releasing radiopharmaceutical investigational medicinal product batches at a drug discovery firm. QP qualification for radiopharmaceuticals per AMG §15 (3a) 5 required. Work with AI-powered drug discovery tools.
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 investigational medicinal products (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
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Novartis Pharma AG
Industry
Pharmaceuticals
Description
The company is committed to integrating AI-powered tools into drug discovery to enhance data-driven solutions.
Not a perfect match?
- Novartis Pharma AG
Qualified Person Radiopharmaceuticals(m/w/x)
Full-timeOn-siteNot specifiedNürnberg - CSL Plasma
Qualitätsmanagementbeauftragter(m/w/x)
Full-timeOn-siteExperiencedNürnberg - ABF Unternehmensverbund
Pharmazeut:in im Praktikum für die Qualitätssicherung(m/w/x)
Full-timeInternshipOn-siteFürth - WILAmed GmbH
Quality Management Specialist Medizintechnik(m/w/x)
Full-timeOn-siteExperiencedKammerstein - Novartis Business Services GmbH
Site Quality Head(m/w/x)
Full-timeOn-siteSeniorNürnberg, Halle (Saale), Dresden, Leipzig