Quality Operations Specialist
By Admin · Quality Assurance & Quality Control
ROLE OVERVIEW
Novartis is seeking a Specialist, Quality Operations in Hyderabad to safeguard GxP conformity across its pharmaceutical quality management system. This role sits at the intersection of compliance, change control, audit readiness, and continuous improvement, directly supporting the delivery of safe, effective medicines. By managing change controls, GxP documentation, and quality KPIs, the specialist helps prevent compliance risks that could delay regulatory approvals or commercial supply. The position offers a compelling opportunity to work within a global healthcare leader, partner with cross-functional stakeholders, and deepen expertise in Novartis Quality Management Systems. For quality professionals seeking broad exposure to audits, investigations, and operational excellence, this role provides a strong platform for career progression in Hyderabad’s thriving life-sciences hub.
ROLE DEFINITION & RESPONSIBILITIES
- •Manage change controls from initiation through closure using approved Novartis digital quality systems, ensuring accurate impact assessments and timely approvals.
- •Execute assigned quality activities in compliance with GxP, Novartis QMS, and regulatory requirements while meeting agreed timelines.
- •Author, review, and revise GxP documents including SOPs, trend reports, qualification reports, and deviation investigations.
- •Support internal and external audits by compiling process documentation, data packages, and quality reports for inspectors.
- •Generate, analyze, and distribute quality KPIs and dashboards to support governance meetings and management reviews.
- •Escalate GxP and non-GxP issues, support root cause analysis, and follow up on CAPA actions arising from quality processes.
- •Perform designated roles such as CRB Facilitator, Entity Data Manager, or Business Approver as required by business needs.
- •Maintain data integrity, compliance with standard operating procedures, and readiness for regulatory inspections across assigned areas.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Master’s degree in Science, Engineering, Pharmacy, or an equivalent qualification.
- Minimum of 6 years’ progressive experience in Quality Assurance, Regulatory Affairs, Pharmaceutical Manufacturing, or Medical Devices.
- Demonstrated hands-on knowledge of change control, quality systems, and GxP documentation.
- Proven stakeholder management and project coordination skills across cross-functional and global teams.
- Strong data analysis, reporting, and proficiency in enterprise digital tools and MS Office applications.
- Basic understanding of GxP requirements, data integrity, and regulatory compliance expectations.
- Experience in a global or matrixed pharmaceutical environment is preferred.
PREFERRED QUALIFICATIONS
- •Project Coordination
- •CRB Facilitation
- •Entity Data Management
- •Operational Excellence / Lean Six Sigma
- •Global Audit Readiness
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
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.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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