workday
Quality Associate III
Vantive
Bengaluru, IND
Full-time
Senior · 10+ years experience
Onsite
Discovered 1 weeks ago
LIMSELNPDLM
Free
Job Fit Check
Base Career helps you apply smarter for this job.
?%
Ready to ScanKey skills for this role
LIMSELNPDLM
Role Overview
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.
Key Skills for This Role
LIMSELNPDLM
Full Job Posting
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).
- Participate in health authority inspections and audits.
- Ensure integrity and traceability of analytical data (ALCOA+ principles).
- Oversee electronic systems qualifications & usage such as LIMS, ELN, and data management tools.
- Identify and mitigate data integrity risks.
- Lead investigations related to data inconsistencies.
- Perform CAPA reviews and provide input to management reviews.
- Support CRO OOL, OOS and provide insight to the ongoing Investigations and SCAR’s.
Apply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at Vantive
Principal Eng, Systems
Bengaluru, IND
Discovered YesterdayFull-time
Consultant, ERP Finance Modernization & Transformation Lead
Bengaluru, IND
Discovered 3 days agoFull-time
Medical Field Service Engineer
London, GBR
Discovered 3 days agoFull-time
Senior Key Account Manager
London, GBR
Discovered 3 days agoFull-time
Bilingual Contracts & RFP Specialist (French & English)
Mississauga, CAN
Discovered 1 weeks agoFull-time
Master Data Management Business Analyst-2
Bengaluru, IND
Discovered 1 weeks agoFull-time
Mgr, Program
Bengaluru, IND
Discovered 1 weeks agoFull-time
Principal Eng, Risk
Bengaluru, IND
Discovered 1 weeks agoFull-time