Quality Manager / Qualified Person

Beschreibung:

Job Description SummaryEU Local Distribution Qualified Person for investigational medicinal products IMPs and auxiliary medicinal products AMPs

Job Description
Major Accountabilities:
* Batch certification / batch release of investigational medicinal products IMPs and auxiliary medicinal products AMPs in EU Local Distribution
* Collaboration with local COs (SSO, Depot, NCQ)
* Review and approval of quality-relevant Documentation to support batch release
* Ensure compliance with local and international regulations
* 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
* Reporting of technical complaints / adverse events / special case scenarios related to Novartis products

Work Experience:
* Audit & Inspection Management
* Quality Management Systems
* Quality Assurance
* GxP Experience
* Good Manufacturing Practices (cGMP)
* Quality Compliance
* Drug Development
* Research
* Technological Expertise
* Complaints Management
* Good Laboratory Practice (GLP) Analytics
* Incident Management
* Deviation Management
* Corrective and Preventive Action (CAPA) Knowledge
* Third Party Management
* Change Control Management
* SOP (Standard Operation Procedure) Management
* Patient Safety
* Pharmacovigilance

Skills:
* Pharmacist
* Qualification as a Qualified Person according to EU Legislation

Languages:
* English

Skills DesiredBusiness Partnering, Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge