Job Description

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.

Your key responsibilities:
Your responsibilities include, but not limited to:

• Extract data from relevant sources in Novartis tools/ applications. Interpret and compile external supplier APQR and extracted data from Internal Novartis systems into a pre-defined template and draft conclusion of product quality review.
• Collect contributory reports for product related evaluations. Interact with CMOs and / or manufacturing sites as required. Support in updating and maintenance of APQR schedule.
• Perform review of APQR report/ data as applicable to ensure it is complete and correctness. Complete APQRs within defined timelines. Archive the approved APQR as applicable. Communicate with external suppliers to provide applicable APQR to QSC.

• Experiences in drafting of Quality assurance agreement and Quality risk assessment for CMO's / suppliers. Understanding on Audits & CAPA management for suppliers. Strong understanding on Quality Management System and GxP requirements.
• Exposure of corporate functions and stakeholder management. Provide support in preparation, review and approval of GMP documents including local and global SOPs, WP's, Investigation reports, etc., where required.
• Ensure implementation of applicable Novartis QMS requirements at NTO GOC, QSC and CTS. Provide support as key user/ Super user for IT tools used for Quality Management System.

Minimum requirements

What you'll bring to the role:

• Minimum 6 years of working experience in a pharmaceutical Quality Assurance or manufacturing, Quality Control with 5+yrs of experience in APQR writing. Good knowledge in GMP.
• Profound knowledge of National/International pharma regulations. Exposure in implementing and continuously improving robust quality systems and processes and maintaining global quality standards in regulated areas.
• Good knowledge of risk-based approaches in product lifecycle management. Excellent understanding of business processes, supply chain principles and practices as well as supporting systems and applications
• Good communication and interpersonal skills, Project management skills and Change management skills.
• Good application knowledge (SAP, AQWA). In-depth GxP knowledge, Quality Risk Management, broad IT knowledge, continuous improvement
• Skills to deliver virtual and F2F Facilitation trainings. Provide pragmatic solutions to ensure compliance applicable regulations. Experience of working closely with the global stakeholders and negotiation skills.

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

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.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Functional Area

Quality

Division

Novartis Technical Operations

Business Unit

NTO QUALITY

Employment Type

Regular

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No