Quality Operations Partner, AS&T Specialist

Quality Operations Partner, AS&T Specialist

The Quality Operations Partner, AS&T Specialist performs analytical tasks in responsibility of AS&T group to support AS&T Experts in overall management of their projects. 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. Support analytical Life Cycle Management for commercial products and support timely analytical implementation for new projects.

Major accountabilities:

• Support management of all analytical activities related to projects within in responsibility of AS&T group
• Support Life-cycle management of analytical methods, including control of method performance, analytical method improvements, pharmacopoeia and health authority compliance (support subject matter expert in health authority inspections)
• Single point of contact for internal and external clients and contract laboratories, if applicable.
• Support timely analytical implementation (Method Transfer and Method Validation) for (new) projects in the course of product transfers
• Setup and monitoring of stability studies
• Support overarching product investigations cross functional, e.g. QC, QA, Production, MS&T
• Support implementation of GMP requirements. Support compilation and review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents)

Minimum Requirements:

• Education : M.Pharm/ Engineering/MSc/M.Tech/equivalent from a reputed institute.
• Experience : Minimum 5 years' experience in Quality Assurance, Quality Control, 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.
• Languages: English fluent, written and spoken.

Skills Desired

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