Specialist, Quality Operations

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

Job summary

Novartis Healthcare Private Limited in Hyderabad, India, seeks a Specialist, Quality Operations to lead end-to-end supplier quality management and regulatory compliance. The role requires 8+ years in QA with a pharma degree and strong expertise in supplier QA processes.

Responsibilities include drafting QA agreements, managing changes, risk assessments, and audit support. This on-site position offers a full-time schedule and collaboration with multiple internal stakeholders in a regulated

Qualifications

• 8 years of experience in supplier quality or related field.
• Education: M Pharma / B Pharma / MSc or equivalent from a reputed university.

Responsibilities

• Lead end-to-end supplier quality management activities.
• Draft and negotiate QA agreements with suppliers/service providers.
• Manage supplier change notifications and quality records.
• Conduct quality risk assessments for existing and new suppliers.
• Coordinate audits, CAPA, and disposition of discrepant materials.

Skills

Supplier Quality Management

Quality Risk Assessment

Change Control

Audit Preparation

Education

M Pharma / B Pharma / MSc

Tools

3rdPAP Management tool

SIM (Supplier Information Management)

Job description

#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.

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.

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. How can we achieve this? 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

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