QP / Senior Quality Manager Radiopharmaceuticals

Job Description Summary

Responsible as a Qualified Person for investigational medicinal products IMPs ((NCEs, Biologics und RLTs) according to §14 AMG (German Drug Law).

 

Job Description

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.

 

Skills Desired

Agility, Analytical Development, Auditing, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, Six Sigma, Sop (Standard Operating Procedure), Technological Expertise