Specialist / Associate Manager - MS&T (Investigation and Deviation management)

HYDERABAD (IN)ONSITEPOSTED: 8/12/2026
PHARMAFull-time
HIRING ORGANIZATIONNOVARTISPharmaceuticals / Healthcare
Novartis

ROLE DEFINITION & RESPONSIBILITIES

Take ownership of deviation management, technical complaints, and OOX investigations within the biologics manufacturing site.
Lead complex root cause analysis (RCA) using structured tools like 5 Whys, Fishbone diagrams, process mapping, and impact assessments.
Define, execute, and monitor Corrective and Preventive Actions (CAPA) and effectiveness checks (EC) across cross-functional operations.
Author and review comprehensive investigation reports with strong scientific rationale and regulatory compliance.
Apply Quality Risk Management (QRM) frameworks and conduct risk assessments to guide decision-making and continuous improvement.
Support health authority inspections, internal audits, and maintain readiness for regulatory interactions in large-molecule facilities.

REQUIRED VERIFIED SKILLS

Root Cause Analysis
Deviation Management
CAPA
Quality Risk Management
Biologics Manufacturing
cGMP
Process Control

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

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