Summary
Responsible as a Qualified Person for investigational medicinal products IMPs ((NCEs, Biologics und RLTs) according to §14 AMG (German Drug Law).
About the Role
Major accountabilities:
* Responsible for batch certification / batch release of investigational medicinal products IMPs (NCEs and Biologics)
* Responsible for batch certification / batch release of radiopharmaceutical investigational medicinal products IMPs
* Review and approval of Quality-relevant Documentation to support batch release
* Ensure compliance with local and international regulations, in particular with German Drug Law, AMWHV
* Continous improvement of QA system and processes
* Systematic improvement of Compliance and operational level
* CAPA Management
* Support in Complaint handling
* Change Control Management
* SOP preparation and review
* self-reliant Project Management
* active collaboration in quality related projects across teams
* Training of interns & student apprentices
Minimum Requirements:
* Pharmacist
* Qualification as a Qualified Person according to AMG §15
* Qualification as a Qualified Person for radiopharmaceuticals according to AMG §15 (3a) 5.
Skills:
* Profound knowledge of pharmaceutical regulations (e.g. Radiopharmaceuticals, German Drug Law, AMWHV)
* Proactive, self-initiated way of work with high sense of responsibility
* Analytical way of thinking, flexible and solution oriented workstyle by maintaining a close collaboration with other teams and country organizations
* Strong organisational and persuasional skills as well as high developed communication competencies across in international teams
Languages :
* German
* English
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability. The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.
Unterstützungen für BewerberInnen mit Behinderungen:
Das Gesetz sieht für schwerbehinderte/gleichgestellte Bewerber die Möglichkeit vor, die lokale SBV in dem Bewerbungsprozess einzubinden. Sollte dies Ihrem Wunsch entsprechen, teilen Sie es uns bitte im Vorfeld als Vermerk in Ihrem Lebenslauf mit.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally:
Division
Development
Business Unit
Quality
Location
Germany
Site
Nuremberg (Non-Sales Force) (Novartis Pharma GmbH)
Company / Legal Entity
DE14 (FCRS = DE014) Novartis Pharma GmbH
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability. The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.