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Quality Associate III
Vantive
Bengaluru, IND
Full-time
Mid-Senior
Onsite
Discovered 1 weeks ago
Analytical quality assuranceAnalytical chemistryHPLCGas chromatographySpectroscopyDissolution testing
Free
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Analytical quality assuranceAnalytical chemistryHPLC
Role Overview
Responsible for ensuring analytical activities, data, and documentation meet global quality and regulatory requirements.
Supports product registrations by ensuring analytical data integrity, compliance, and audit readiness.
Key Skills for This Role
Analytical quality assuranceAnalytical chemistryHPLCGas chromatographySpectroscopyDissolution testing
Full Job Posting
About Vantive
Vantive develops vital organ therapies and digital solutions intended to improve the dialysis experience and patient care.
The company focuses on extending lives and expanding possibilities for patients and care teams worldwide.
Role Summary
Responsible for ensuring analytical activities, data, and documentation meet global quality and regulatory requirements.
Supports product registrations by ensuring analytical data integrity, compliance, and audit readiness.
Essential Duties and Responsibilities
- Provide quality assurance oversight for internal and external analytical laboratories.
- Review and approve method validation, stability, specifications, test methods, and certificates of analysis documentation.
- Review and approve extractables and leachables studies and OOS, OOT, deviation, and incident investigations.
- Ensure analytical work complies with GMP, GLP, data integrity, and ALCOA+ principles.
- Monitor laboratory compliance, drive quality improvements, and support global registrations.
- Participate in health authority inspections and audits.
- Oversee LIMS, ELN, and data management system qualification and use.
- Identify data integrity risks and lead investigations into data inconsistencies.
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