Novartis is hiring for the role of Quality Assurance Operations Specialist in Hyderabad (Office). This on-site opportunity is part of the Quality Assurance department and is suitable for candidates with relevant experience in quality assurance, regulatory, or pharmaceutical manufacturing operations.
Job Details
| Company | Novartis |
|---|---|
| Position | Quality Assurance Operations Specialist |
| Department | Quality Assurance |
| Location | Hyderabad (Office) |
| Qualification | MBA, Master’s Degree |
| Experience | 3+ Years |
| Work Mode | On-site |
| Application Mode | Online Application |
Job Description
The Quality Assurance Operations Specialist will provide quality services in compliance with cGMP requirements and the Novartis Quality Management System, as defined and agreed between QOP and business partners. The role involves managing quality aspects and projects within the assigned area of responsibility.
Key Responsibilities
- Comply with internal procedures and systems, including KPI reporting, ticket management, time tracking, workflow applications, and other functional processes.
- Support business needs through ad hoc administrative activities, assigned tasks, trainings, and ownership of deliverables with accuracy and timeliness.
- Communicate regularly with customers, partners, sites, suppliers, CMOs, and internal teams to gather feedback, coordinate activities, and support service delivery.
- Ensure adherence to Novartis quality standards, GxP requirements, regulatory expectations, operating procedures, and applicable legal, IT, and P&O requirements.
- Create, review, analyze, and maintain GxP documentation and reports, including SOPs, working procedures, trend reports, qualification reports, technical investigations, and ad hoc reports.
- Support audits, quality operations, product quality compliance, regulatory workflows, CAPA management, process improvements, and Master Data Management activities as required.
- Manage complaints by receiving, reviewing, processing, investigating, approving, trending, reporting, and closing complaint records in applicable QMS tools.
- Coordinate complaint-related activities with CMOs, suppliers, Country Organizations, sites, and complaint hubs, including documentation, sample availability, supplier investigations, deviations, actions, and follow-up activities.
Qualification
- MBA
- Master’s Degree
- Education in Pharmacy, Science, MBA, Engineering, or an equivalent qualification from a reputed institute.
Experience
Minimum 3 years of experience in Quality Assurance, Regulatory, or manufacturing of pharmaceutical drug substances, products, or medical devices is required.
Required Skills
- Strong understanding of GxP requirements and basic IT knowledge.
- Fluent in English, both written and spoken.
- Good communication, presentation, and interpersonal skills.
- Experience working closely with global stakeholders.
- Collaboration, Communication, Data Integrity, Good Manufacturing Practices (GMP), Internal Quality Auditing, Managing Ambiguity, Operational Excellence, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Compliance, Standard Operating Procedure (SOP), and Statistical Process Control (SPC).
Benefits
Novartis has shared benefits and rewards information through the Novartis Life Handbook.
https://www.novartis.com/careers/benefits-rewards
How to Apply
Interested candidates can apply online through the official Novartis careers application link.