Band
Level 3

Job Description Summary
LI-Hybrid

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.

The Specialist, Quality Operations is responsible for the End to End supplier / Vendor / Third Party Quality management activities.

Job Description
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 recent 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 R

📌 Specialist, Quality Operations (Hyderabad)
🏢 Novartis
📍 Hyderabad