Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners
Job Summary
Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners.
Support manufacturing sites with QC and related activities including authoring testing monographs and risk evaluation reports for Nitrosamines.
Ensure compliance to internal quality standards, relevant regulatory requirements, and provide active support during internal and external audits.
Matching Summary
Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners.
Skills & Requirements
Must-have
Quality Management System compliance
cGMP requirements adherence
Quality Control release activities
Risk evaluation report authoring
Statistical support and performance trending
Support during internal and external audits
Nice-to-have
Collaboration
Communication Skills
Data Integrity
Dealing With Ambiguity
Digital saviness
Leadership
Operational Excellence
Problem Solving Skills
Key Requirements
Minimum 3 years experience in Quality Assurance or Regulatory