Quality Operations Partner, AS&T Expert

Quality Operations Partner, AS&T Expert

Job Description 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 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

Major accountabilities:

• Management and oversight of all analytical activities related within responsible projects.

• Perform activities related to equipment qualifications and computer system validations.

• Support ELN building or master building activities for LIMS.

• 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).

Essential Requirements:

• Education: M.Pharm/ MBA / M.Tech/MSc/Engineering/equivalent from a reputed institute.

• 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 environment and diverse team representative of the patients and communities we serve.

Accessibility and Accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired

Collaboration, Data Integrity, Leadership

Experience Level

Senior Level