About this role

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? https://www.novartis.com/about/strategy/people-and-culture