Mindblowing Jobs

Specialist - Quality Operations

By Admin · Quality Assurance & Quality Control

HYDERABAD (IN)ONSITEPOSTED: 8/25/2026
PHARMAFull-time
HIRING ORGANIZATIONNOVARTISPharmaceuticals / Healthcare
Novartis

ROLE DEFINITION & RESPONSIBILITIES

Role & Organizational Overview

The Specialist - Quality Operations at Novartis in Hyderabad (Level 3 Band) supports critical product quality, batch release preparatory work, Quality Management System (QMS) execution, and regulatory compliance checks. Operating in a GMP-regulated environment, this role ensures batch release readiness and compliance with Novartis quality standards and international health authority guidelines.

Core Responsibilities

Batch Release & Technical Verification: Execute batch release preparatory tasks, technical release verifications, and regulatory compliance checks according to established standard operating procedures (SOPs).
QMS & Deviation Management: Support core QMS activities including deviation management, quality event handling, compliance follow-up, root-cause investigations, and corrective action implementations.
GxP Documentation & Audit Support: Create, review, and maintain GxP documentation such as SOPs, qualification reports, trend analyses, and working procedures. Provide direct support during internal and external regulatory audits.
Master Data & Product Quality Execution: Support master data governance, Bill of Materials (BOM) approval workflows, Certificate of Analysis (CoA) generation, and GxP/non-GxP issue escalations.
Reporting & Operational Metrics: Generate, analyze, and present reports from approved enterprise systems to drive operational monitoring, digital quality initiatives, and key performance indicator (KPI) tracking.

Technical & Domain Standards

Strict adherence to Good Manufacturing Practices (GMP) and GxP requirements across batch release and QA workflows.
Maintenance of Data Integrity and Statistical Process Control (SPC) in quality documentation and reporting.
Compliance with global regulatory requirements, health authority guidelines, and Novartis internal quality governance.

Leadership & Business Impact

Ensures product quality and compliance integrity before release, driving operational excellence and audit readiness across commercial drug product batches.

REQUIRED VERIFIED SKILLS

Quality Assurance
Quality Management Systems
Good Manufacturing Practices
Batch Release
Deviation Management
GxP Documentation
Regulatory Compliance
Certificate of Analysis

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting

ORGANIZATION CONTEXT & CULTURE

Novartis AG is a Swiss multinational pharmaceutical corporation, one of the largest in the world. It focuses on discovering, developing, manufacturing, and marketing innovative medicines to address significant health needs. The company's portfolio spans various therapeutic areas including oncology, immunology, neuroscience, and cardiovascular diseases.

TEAM SIZE: 76,000+ employees
INDUSTRY: Pharmaceuticals / Healthcare
RECOMMENDED TRAINING
1/5
Industry Essentials: PV, CR, CDM, RA & Quality

Industry Essentials: PV, CR, CDM, RA & Quality

READY TO SUBMIT?

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