Job Description Summary
-Manages Quality aspects and projects within area of responsibility.
-Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.
Job Description
Major Accountabilities:
- QC/ QA in pharmaceutical ind./ biotech with environmental monitoring & cleanliness zones, Functional Breadth, Collaborating across boundaries
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
- Distribution of marketing samples (where applicable)
Key Performance Indicators:
- On-time and GMP-compliant release of dosage forms
- No complaints about inspections by authorities in your own area of responsibility without these being noticed & communicated beforehand
- Successfully support continuous improvement projects<LI>Executes batch release in compliance with registration
Work Experience:
- Quality Assurance
- Quality Control
- Quality Management Systems
- Technological Expertise
- Environmental Monitoring
- Release Management
- Good Manufacturing Practices (cGMP)
- Audit & Inspection Management
- Quality Compliance
- Technological Expertise
Skills:
- Collaboration
- Dealing With Ambiguity
- Operational Excellence
- Regulatory requirements knowledge
- Problem Solving Skills
- Leadership
- Communication skills
- Data Integrity
- Digital saviness
Languages:
Skills Desired
Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge
