Quality Associate III (Bengaluru)

Quality Associate III (Bengaluru)

06 Sep
|
Vantive
|
Bengaluru

06 Sep

Vantive

Bengaluru

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.
We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.
Summary: Responsible for ensuring that all analytical activities, data,



and documentation meet global quality and regulatory requirements. This role plays a critical part in supporting product registrations by ensuring analytical data integrity, compliance, and audit readiness.

Essential Duties and Responsibilities:
Provide QA oversight for analytical laboratories (internal and external).
Review and Approve Analytical method validation protocols and reports, Stability study protocols and reports, Specifications and test methods and Certificates of analysis (CoA).
Review and Approve extractables and leachables study plans, protocols, and reports.
Review and approve investigations for; OOS (Out of Specification), OOT (Out of Trend), Deviations and Incidents.
Ensure all analytical work complies with GMP, GLP, and Data Integrity principles.
Monitor lab compliance and drive quality improvements.
Ensure analytical data meets requirements for global registrations (e.g., US FDA, EMA, ROW).
Participa

📌 Quality Associate III (Bengaluru)
🏢 Vantive
📍 Bengaluru

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