Band

Level 4

Job Description Summary

EU 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 Desired

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