Quality Assurance Operations Specialist
Skills
About the role
This is a Quality Assurance Operations Specialist role at Novartis, a pharmaceutical company, based on-site in Hyderabad. The specialist provides quality services in line with cGMP requirements and the Novartis Quality Management System, handling complaints, documentation and audit support. It suits someone with 3+ years of experience in quality assurance, regulatory work, or pharmaceutical manufacturing operations.
What you’ll do
- Comply with internal procedures including KPI reporting, ticket management and time tracking
- Support business needs through administrative activities and assigned tasks
- Communicate with customers, partners, sites, suppliers and CMOs to coordinate activities
- Ensure adherence to Novartis quality standards, GxP requirements and regulatory expectations
- Create, review, analyze and maintain GxP documentation including SOPs and investigation reports
- Support audits, product quality compliance, CAPA management and Master Data Management activities
- Manage complaints including receiving, reviewing, investigating, approving and closing complaint records
- Coordinate complaint-related activities with CMOs, suppliers, sites and complaint hubs
What they’re looking for
- MBA or Master's Degree in Pharmacy, Science, Engineering or an equivalent qualification
- Minimum 3 years of experience in Quality Assurance, Regulatory, or manufacturing of pharmaceutical drug substances, products, or medical devices
- Strong understanding of GxP requirements and basic IT knowledge
- Fluent in English, written and spoken
- Good communication, presentation and interpersonal skills
- Experience working closely with global stakeholders
What’s on offer
- On-site role in Hyderabad
- Benefits detailed in the Novartis Life Handbook
Questions about this role
Is this role remote?
No, it's an on-site role based in Hyderabad.
How many years of experience do I need?
A minimum of 3 years in Quality Assurance, Regulatory, or pharmaceutical/medical device manufacturing.
Do I need a degree?
Yes, an MBA or Master's Degree, or education in Pharmacy, Science, Engineering or an equivalent qualification.
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