PHARMAFull-time
Specialist, Quality Operations
By Admin · Quality Assurance & Quality Control
HYDERABAD (IN)HYBRIDPOSTED: 9/17/2026
PHARMAFull-time
HIRING ORGANIZATIONNOVARTISPharmaceuticals / Healthcare
ROLE OVERVIEW
Manage quality operations, GxP compliance and quality-system projects within the assigned area, ensuring compliant execution of change controls, documentation, audits, investigations, reporting and governance activities.
ROLE DEFINITION & RESPONSIBILITIES
- •Manage Change Controls from initiation through closure using approved Novartis systems
- •Ensure timely, accurate and compliant execution of assigned quality activities
- •Support KPI reporting, governance activities and business-process requirements
- •Create and review GxP documents, SOPs, trend reports, qualification reports and investigations
- •Support internal and external audits by providing process documentation, data and reports
- •Escalate GxP and non-GxP issues and support investigations
- •Generate and analyze quality-process reports and follow up on resulting actions
- •Perform designated roles such as CRB Facilitator, Entity Data Manager and Business Approver
- •Maintain compliance with Novartis quality standards, regulatory requirements and operating procedures
Reporting Hierarchy: Reports to the relevant Quality Operations leadership; works cross-functionally with quality, manufacturing, regulatory and business stakeholders and supports governance and audit activities
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Master's degree in Science, Engineering or equivalent qualification
- Minimum 6 years of experience in Quality Assurance, Regulatory Affairs, Pharmaceutical Manufacturing or Medical Devices
- Stakeholder management and project coordination skills
- Knowledge of change control and quality systems
- Data analysis and reporting capabilities
- Proficiency in enterprise digital tools and MS Office
- Basic understanding of GxP requirements
PREFERRED QUALIFICATIONS
- •Experience with GMP, internal quality auditing, quality management systems and regulatory compliance
- •Experience with data integrity, operational excellence and quality control
- •Knowledge of Statistical Process Control (SPC)
- •Experience with Novartis or comparable enterprise quality systems
REQUIRED VERIFIED SKILLS
GxP
GMP
Quality Assurance
Quality Control
Quality Management Systems
change control
regulatory compliance
SOP
data integrity
internal quality auditing
investigations
audit support
KPI reporting
data analysis
MS Office
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Benefits and rewards through the Novartis Life Handbook, paid leave, professional development opportunities and standard employee benefits
The source posting does not disclose salary or bonus/equity figures. Compensation would be determined according to Novartis compensation structures, experience and applicable location factors.
ORGANIZATION CONTEXT & CULTURE
Novartis is a global medicines company focused on reimagining medicine and developing innovative therapies to improve and extend patients' lives.
TEAM SIZE: 75,000+ employees
INDUSTRY: Pharmaceuticals / Healthcare
Culture: Novartis emphasizes an inclusive, collaborative environment, operational excellence, quality, compliance and a mission-driven approach to improving patient outcomes.
EXPECTED CAREER ROADMAP
Potential progression includes Senior Quality Specialist, Quality Operations Manager, Quality Systems leadership, QA management and broader GxP compliance or regulatory quality roles.
APPLICATION ADVISORY
Emphasize 6+ years of quality, regulatory, pharmaceutical manufacturing or medical-device experience; highlight hands-on change-control and QMS experience; demonstrate GxP/GMP knowledge; mention audit and investigation experience; showcase KPI/data reporting skills and stakeholder coordination; include experience with SOPs, CAPA-related investigations, data integrity or SPC where applicable.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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