Specialist Quality Operations

Sep 06, 2021

Job Description

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.

Job Purpose:
Provide Quality Service in compliance with cGMP regulatory requirements and the Novartis Pharma Quality Manual and Policies by implementing processes, systems and tools that realize the Quality Operations services across Novartis divisions.

Your responsibilities include, but not limited to

• Prepare Regulatory Statements/declarations, Quality Assurance Agreement, Quality Risk Assessment for excipients, Regular Material-/Supplier-Monitoring and packaging material as per agreed tasks with the customers.
• Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows
• Hold accounts in workflow applications (like SAP, Dragon, SUBWAY, TEDI etc.) to ensure appropriate execution of service deliverables
• Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures.
• Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements.
• Support implementing service quality and process improvement projects, CAPA management within Quality Service Centers.
• Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes.

Minimum Requirements

What you’ll bring to the role:

• M.Pharm/ MBA / Engineering/equivalent from a reputed institute.
• Min 3yr Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/Medical device.
• GxP-knowledge, Broad IT-knowledge
• Fluent in English (written and spoken)
• Good communication, presentation and interpersonal skills. Experience of working closely with the global stakeholders

Why consider Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

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
Novartis Technical Operations
Hyderabad, AP
Full Time
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Specialist Quality Operations

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