Specialist, Quality Operations

Novartis is hiring a Specialist, Quality Operations in Hyderabad, India. Level rates it ; you can apply on Novartis.

Level's read on this job

Little AI ●○○○ is how Level rates this role: aI is not part of the work.
The posting mentions SharePoint, quality assurance and gxp among its tools and skills.
Level classes it as a senior role.
Novartis has 835 other open roles on Level.
Posted within the past two weeks.

AI in this role

Manages quality operations, GxP compliance, and quality documentation like SOPs and CAPA investigations.

sharepoint

quality-assurancegxpcompliancedeviation-management

Job Description Summary

About the role:

Manages Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.

Job Description

Key Requirements:

Deliver Quality Operations and Quality Compliance activities in line with GxP, regulatory requirements, internal quality standards and SOPs.
Manage and support quality documentation, including SOPs, working procedures, process maps, trend reports, qualification reports and technical investigations.
Support deviations, quality events, investigations and CAPA management, including tracking, trending and timely closure.
Support internal/external audits, inspections, self-inspections and supplier audit activities.
Manage quality-related activities across APQR, QAA, QRA, KQI metrics and Approved Supplier Lists.
Support vendor/supplier quality management, including supplier onboarding, assessments, agreements and monitoring.
Generate and analyze quality metrics and reports using approved systems/tools and ensure accurate, timely deliverables.
Maintain quality records, trackers, SharePoint content and relevant documentation.
Partner effectively with internal stakeholders, customers and business partners while supporting continuous process improvement.

Essential Requirements:

Good understanding of GxP, Quality Operations and Quality Compliance requirements.
Experience 5-7 years.
Hands-on experience with deviations/quality events, investigations and CAPA.
Experience creating/reviewing SOPs and other GxP/quality documentation.
Experience supporting audits, inspections and compliance activities.
Ability to work with quality systems/tools, generate reports and track quality metrics.
Strong attention to accuracy, compliance, ownership and timely delivery.
Ability to effectively communicate and collaborate with cross-functional stakeholders and business partners.

Desirable Requirements:

Experience with APQR, QAA, QRA, KQI reporting and Self-Inspection planning.
Exposure to supplier/vendor quality management, supplier audits and Approved Supplier Lists.
Experience with 1QEM / Quality Event Management and Quality Analytics tools.
Exposure to GMP external audits, Health Authority inspections and supply-chain quality.
Experience managing SharePoint, quality repositories, trackers and document archival.
Exposure to Quality Management Review metrics/reporting and continuous improvement initiatives.

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)

How we rate this

Specialist, Quality Operations at Novartis rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.

Key facts

Specialist, Quality Operations is an open job at Novartis.
Level rates this role AI Level 1 of 4: Little AI.
The role is based in Hyderabad (Office).
The job was posted on October 15, 2026.
Seniority: senior.
Applications are handled by Novartis. Apply on Novartis

Prepare for this job

Built from this posting and from similar jobs on Level.

Skills and AI tools this role asks for

Quality AssuranceGxpComplianceDeviation ManagementSharePoint

Questions you could be asked

Tell me about a project where quality assurance was part of your work. What did you do?
Tell me about a project where gxp was part of your work. What did you do?
Tell me about a project where compliance was part of your work. What did you do?
Tell me about a project where deviation management was part of your work. What did you do?
Walk me through how you've used SharePoint in your day-to-day work.

Adapt your resume

List these exact terms on your resume: Quality Assurance, Gxp, Compliance, Deviation Management, and SharePoint. An applicant tracking system matches the wording, not the idea.
Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.

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