Specialist, Quality Operations

Novartis India; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Novartis India is seeking a skilled professional for a Supplier Quality Management role based in Hyderabad, India. The candidate will draft and negotiate QA agreements, manage supplier change notifications, and prepare regulatory statements for materials and finished products.

Expect responsibilities including audit support, CAPA management, and collaboration across stakeholders in third-party risk management tools. Requires around 8 years of relevant experience and a pharma background.

Qualifications

• Around 8 years of experience in supplier quality management.
• Education: M Pharma, B Pharma or MSc from a reputed university.
• Languages: English.

Responsibilities

• Draft/author annual monitoring and certification reports for incoming materials.
• Draft and negotiate Quality Assurance Agreements with suppliers/ service providers.
• Evaluate supplier change notifications (SCN) and initiate quality records.
• Prepare regulatory statements for materials and finished products.
• Support audit preparation, CAPA management, and 3rd Party Risk Management tooling.
• Coordinate in SIM approval processes for quality deliverables.
• End-to-end delivery of supplier quality management tasks as delegated.

Skills

Supplier Quality Management

Quality Assurance

English

Education

M Pharma / B Pharma / MSc

Job description

Summary

Location: Hyderabad, India

This role is based in Hyderabad, India. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

About The Role

Major accountabilities:

Supplier Quality Management

• Drafting / Authoring of Annual Monitoring and Certification report for incoming materials.
• Drafting / Negotiation (if applicable) and Archival of Quality Assurance Agreement with Suppliers/Service providers.
• Evaluation and Management of Supplier Change Notifications (SCN) and Initiation of quality record for the applicable SCN.
• Drafting and Evaluation of Supplier’s incoming materials Specification.
• Performing Quality Risk Assessment (QRA) for existing and new Suppliers / Service providers.
• Management of Supplier/ Material qualification and supplier related documentation.
• Preparation of regulatory statement for materials and finished products.
• Management Quality records, Support the Service Delivery team (SDT) with quality topics and 3rdPAP Management in TPRM (Third Party Risk Management) tool.
• Coordination with stakeholders in SIM (Supplier Information Management) approval process for Quality deliverables.
• Preparation of relevant contributing report for respective APQR section.
• Evaluation of change control tasks/ deviations related to supplier quality management.
• Coordination in handling Discrepant Materials & Supplier Complaints.
• Audit preparation support, QARP and FURP Role for audit and CAPA Management.
• Responsible for the Functional representative activities.
• End to end deliverables for supplier quality management activities as per the delegated task from the business partner.

Obligatory Requirements

• Preferable Experience - Around 8 Years
• Education - M Pharma / B Pharma / MSc or Equivalent from Reputed university.
• Languages: English.

Why Novartis:

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment To Diversity And Inclusion

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

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.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Learn about all the ways we’ll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)