Quality Operations Partner, AS&T Expert

Quality Operations Partner, AS&T Expert

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 Good 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.

Job Description

Obligatory requirements:

• Management and oversight of all analytical activities related within responsible projects.
• Life-cycle management of analytical methods, including control of method performance, analytical method improvements, pharmacopoeia and health authority compliance (subject matter expert in health authority inspections)
• Single point of contact for internal and external clients and contract laboratories, if applicable.
• Ensure timely analytical implementation (Method Transfer and Method Validation) for (new) 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

Skills Desired

Collaboration, Communication Skills, Continuous Improvement mindset, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Problem Solving Skills, Regulatory Requirements knowledge