Specialist, Quality Operations

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 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. 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.

 

Skills Desired

Collaboration, Communication, Data Integrity, Good Manufacturing Practices (GMP), Internal Quality Auditing, Managing Ambiguity, Operational Excellence, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Compliance, Standard Operating Procedure (SOP), Statistical Process Control (SPC)