Novartis Hiring for Quality Assurance Operations Specialist

Novartis has announced an opportunity for a Quality Assurance Operations Specialist in Hyderabad. The position is designed for professionals with at least three years of experience in Quality Assurance, Regulatory Affairs, or pharmaceutical/medical-device manufacturing.

The Quality Assurance Operations Specialist will provide quality services in accordance with cGMP requirements and the Novartis Quality Management System (QMS). The position covers GxP documentation, complaint management, CAPA, audits, regulatory workflows, quality compliance and coordination with global stakeholders.

Candidates with an educational background in Pharmacy, Science, MBA, Engineering, or an equivalent qualification can apply, provided they meet the required professional experience and skills.

Job Overview

Key Responsibilities

As a Quality Assurance Operations Specialist at Novartis, the selected candidate will:

• Follow internal procedures and systems covering KPI reporting, ticket management, time tracking, workflows and functional processes.
• Support business requirements through administrative activities, training, assigned tasks and timely completion of deliverables.
• Coordinate with customers, partners, manufacturing sites, suppliers, CMOs and internal teams.
• Ensure compliance with Novartis quality standards, GxP requirements, regulatory expectations and applicable SOPs.
• Create, review, analyze and maintain GxP documentation and quality reports.
• Work with SOPs, working procedures, trend reports, qualification reports and technical investigations.
• Support audits, quality operations, regulatory workflows and product quality compliance.
• Participate in CAPA management, process improvement and Master Data Management activities.
• Receive, review, process, investigate, approve, trend, report and close product complaint records.
• Coordinate complaint investigations with CMOs, suppliers, Country Organizations, manufacturing sites and complaint hubs.
• Follow up on deviations, investigations, documentation, samples and associated corrective actions.

Qualification & Eligibility

Novartis lists the following educational requirement:

Education in Pharmacy, Science, MBA, Engineering, or an equivalent qualification from a reputed institute.

Depending on the institution’s degree nomenclature, relevant educational backgrounds may include:

• B.Pharm
• M.Pharm
• Pharm.D
• B.Sc
• M.Sc
• Relevant Science degrees
• Relevant Engineering degrees
• MBA
• Equivalent qualifications

Applicants should note that the job description does not specify individual B.Sc/M.Sc or Engineering specializations, so candidates should avoid assuming eligibility based solely on degree title if their field is unrelated to pharmaceutical quality operations.

Experience Required

Candidates must have a minimum of 3 years of experience in one or more of the following:

Quality Assurance, Regulatory, or manufacturing of pharmaceutical drug substances, pharmaceutical products, or medical devices.

This is therefore not advertised as a fresher position.

Skills Required

The desired skills for the Novartis Quality Assurance Operations Specialist position include:

• Quality Assurance (QA)
• Quality Management Systems (QMS)
• Good Manufacturing Practices (GMP)
• GxP requirements
• Quality Compliance
• Regulatory Compliance
• CAPA Management
• Complaint Management
• SOP Management
• Data Integrity
• Internal Quality Auditing
• Quality Control (QC)
• Statistical Process Control
• Operational Excellence
• Communication and Collaboration
• Basic IT knowledge

Candidates should also have good written and spoken English, presentation and interpersonal skills, along with experience working with global stakeholders.

Product Complaint Management Responsibilities

Complaint management is an important component of this Novartis QA Operations role.

The specialist may be responsible for receiving and reviewing complaints, processing complaint records within QMS tools, coordinating investigations, evaluating supplier and CMO information, monitoring deviations and corrective actions, trending complaint data and ensuring records are appropriately closed.

This requires strong documentation practices, attention to detail and knowledge of pharmaceutical quality systems.

Why Join Novartis?

This role provides an opportunity to work in a global pharmaceutical quality environment and gain exposure to several important areas, including:

• Global Quality Assurance operations
• Pharmaceutical Quality Management Systems
• GxP and GMP compliance
• Product complaint investigations
• CAPA management
• Audits and regulatory workflows
• Quality documentation
• Supplier and CMO coordination
• Cross-functional and global stakeholder management
• Process and operational improvement

Novartis also highlights its commitment to building an inclusive work environment and providing employee benefits and rewards.

How to Apply

Application Link