Senior Specialist - Quality Engineering

About the role

We are seeking a highly experienced Senior Specialist in Quality Engineering with a strong background in Computer System Validation for our Bangalore team. This role is critical for ensuring the quality and compliance of our life sciences applications through robust testing and validation processes. Lead and execute Computer System Validation (CSV) activities for life sciences applications, ensuring adherence to regulatory standards.

What you'll do

• Lead and execute Computer System Validation (CSV) activities for life sciences applications, ensuring adherence to regulatory standards
• Oversee Quality Assurance Software Testing activities, from planning to execution and reporting
• Develop and optimize IT processes to ensure compliance with relevant regulations and industry standards, including GxP and 21 CFR Part 11
• Collaborate with project and integration management teams to drive quality throughout application development and maintenance projects
• Track, review, and approve all quality deliverables, ensuring accuracy and completeness

What you need

• 8–12 yrs of experience
• ISO 9001
• SOP writing
• ISO 27001
• Data privacy
• Any graduate