346021BR
May 26, 2022
India

Job Description

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

Your key responsibilities:
Your responsibilities include, but not limited to:

• 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. Support implementing service quality and process improvement projects, CAPA management within Quality Service Centers.\\
• Responsible for the extraction and data compilation of analytical, manufacturing (including deviations, complaints, and change requests) and regulatory data (HA commitments, variations) in a predefined format.
• Responsible for collecting stability data and reports for product related evaluations. (e. g. compliance Investigations, divestitures, product transfers, validation. Etc. Support maintenance of APR/PQR schedule.
• Follow-up and tracking of complaint sample availability from Country Organization (CO) to CMO (Contract Manufacturing Organization). Send technical complaints to CMO for investigation. Perform queries in AQWA/Trackwise as per the SOP.
• Perform Quarterly compliant trending and reporting. Perform the role of QA approver for customer complaints delegated to QSC through delegated action.
• Perform a role of change control coordinator or change phase manager in change control management systems like TrackWise and AGILE. Manage different type of change control like product stewardship/Administration Stewardship/Asset Stewardship.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

• M. Pharm/ MBA / Engineering/equivalent from a reputed institute.
• 5+ years’ experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/Medical device. GxP-knowledge, Broad IT-knowledge
• Good communication, presentation and interpersonal skills. Experience of working closely with the global stakeholders
• Experience on MAH review, quality compliance management, technical learning & document management system, product release support, stability support services.

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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
NTO QUALITY
India
Hyderabad, AP
Quality
Full Time
Regular
No
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346021BR

Specialist Quality Operations

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