Specialist - Quality Operations

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

Job summary

Novartis Healthcare Private Limited in Hyderabad seeks an experienced professional to drive end-to-end supplier quality management activities, including drafting and negotiating quality agreements, evaluating supplier change notifications, and performing quality risk assessments. You will coordinate with stakeholders in SIM and support APQR reporting.

Education required is M Pharma / B Pharma / MSc (or equivalent) from a reputed university, with around 8 years of experience.

Qualifications

• Education - M Pharma / B Pharma / MSc or Equivalent from Reputed university.

Responsibilities

• Drafting / Authoring of Annual Monitoring and Certification report for incoming materials.
• Drafting / Negotiation (if applicable) and Archival of Quality Assurance Agreement with suppliers.
• Evaluation and Management of Supplier Change Notifications (SCN) and initiation of quality records.
• 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 with quality topics and 3rdPAP Management in TPRM tool.
• Coordination with stakeholders in SIM 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.

Education

M Pharma / B Pharma / MSc

Job description

End to End Supplier / Vendor Quality Management Activities

About the Role

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
• 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.
• Co-ordination 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.

Preferable Experience - Around 8 Years

Education - M Pharma / B Pharma / MSc or Equivalent from Reputed university.

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

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area Quality

Job Type Full time

Employment Type Regular

Shift Work No

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 [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.