AS&T Specialist - Quality Operations

Job Description Summary

Perform 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.

 

Job Description

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)

Key Performance Indicators:

• Stakeholder orientation and collaboration
• On time and accurately completion of deliverables as per the responsibilities delegated
• Efficiency and Productivity metrics
• Process improvements
• Quality Compliance
• Problem solving skills and Troubleshooting
• Data Integrity
• Regulatory requirements knowledge
• Project Management
• Communication skills
• Continuous Learning.

Minimum Requirements:

 

Education:

M.Pharm/ MBA / Engineering/equivalent from a reputed institute.

Basic awareness of GxP compliance requirements.

Languages:

English

Experiences:

Minimum 5-6 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

Languages:

• English.

 

Skills Desired

Collaboration, Communication Skills (Inactive), Data Integrity, Digital saviness (Inactive), Leadership, Managing Ambiguity, Operational Excellence, Problem Solving Skills (Inactive), Regulatory Requirements knowledge (Inactive)