Novartis Hiring Quality Operations Specialists | B.Pharm/ M.Pharm Graduates | Apply Now
Looking for an exciting opportunity in the pharmaceutical industry? Novartis careers is hiring for the position of Quality Operations Specialist in Hyderabad, India. This is an excellent opportunity for candidates with experience in Quality Assurance, Quality Control, Regulatory Affairs, or pharmaceutical manufacturing to build a rewarding career with one of the world’s leading healthcare companies. This Pharma QA Job offers exposure to batch release activities, GxP compliance, regulatory workflows, and stakeholder management in a global environment.
- Job Title: Quality Operations Specialist
- Job ID: REQ-10076822
- Location: India, Hyderabad (Office)
About the Company
Novartis is a globally recognized pharmaceutical company focused on reimagining medicine to improve and extend people’s lives. The company is committed to innovation, quality, diversity, and creating a healthier future through breakthrough medicines and advanced healthcare solutions.
Job Description
- The Quality Operations Specialist performs batch release activity to support stakeholders in overall management of their projects. Regulatory Compliance Check for batches and their release in SAP.
- Ensures that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures.
- Supports in batch release preparatory activities and timely implementation for new projects.
Key Responsibilities
- Support product quality compliance and regulatory processes.
- Handle additional department tasks as per business needs.
- Communicate regularly with stakeholders and collect feedback.
- Complete assigned training on time and take ownership of tasks.
- Prepare and review GxP documents, SOPs, reports, and investigations.
- Report and help resolve GxP and non-GxP issues.
- Ensure compliance with quality standards and regulatory requirements.
- Support internal and external audits with required reports and data.
- Assist in process improvement projects and CAPA management.
- Perform batch document reviews and regulatory compliance checks.
- Prepare mismatch trend reports and share with stakeholders.
- Support batch release preparation activities for different sites.
Qualification
- Education: B.Pharm/ M.Pharm/MSc/equivalent from a reputed institute.
- Experience: Minimum 2-4 years’ experience in Quality Assurance, Quality Control, Regulatory, or in the manufacturing of pharmaceutical drug substances or products/ medical device/ expertise in Learning management system.
- Basic awareness of GxP compliance requirements.
- Languages: English fluent, written and spoken.
- Stakeholder management and good communication with stakeholders.
- Technological Expertise and intelligence.
- Project coordination.
- Proficiency in MS Office tools.
