QA Officer Operations

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:

• English.

 

Skills Desired

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