Summary:
The Quality Operations Partner, AS&T; Expert is responsible for managing all analytical aspects within responsible projects to ensure that the operational business is in compliance with cGMP (Current Valuable Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures. Ensures analytical Life Cycle Management for commercial products and ensures timely analytical implementation for new projects.
About the Role:
Obligatory requirements:
Management and oversight of all analytical activities related within responsible projects.
Single point of contact for internal and external clients and contract laboratories, if applicable.
Ensure timely analytical implementation (Method Transfer and Method Validation) for (recent) projects in the course of product transfers
Scientific analytical support for quality control, production, registration and marketing
Setup and monitoring of stability studies
Support overarching product investigations cross functional, e.g. QC, QA, Production, MS&T.;
Implementation of GMP requirements. Compilation and review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents)
Minimum Requirements:
Education: M.Pharm/ MBA / M.Tech/MSc/Engineering/equivalent from a reputed institute.
Experiences: Minimum 8 years’ experience in Quality Assurance, Quality Control, AS&T;, Regulatory or in the manufacturing of pharmaceutical drug substances or products/ medical device/ expertise in Learning management system
Problem Solving skills and stakeholder management
Basic awareness of GxP compliance requirements.
English fluent, written and spoken
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work setting and diverse teams' representative of the patients and communities w