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Quality Assurance Analyst at Krishna Chemicals — Gurugram | Apply 2026 | 3ranga
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Quality Assurance Analyst Full-time via indeed
To ensure that all products are manufactured and released in compliance with **regulatory, statutory, and quality requirements**, maintaining a robust **Quality Management System (QMS)**.
*Quality Management System (QMS)**
* Establish and maintain QMS as per ISO 13485 EU MDR (2017/745\) FDA (21 CFR Part 820 / QSR)
* Approve BMR/BPR SOPs Change controls
Ensure **document control and traceability**
* Oversee Incoming inspection In\-process inspection Final inspection *CAPA \& Risk Management**
* Lead Deviation handling Root Cause Analysis (RCA) CAPA implementation Implement **ISO 14971 Risk Management** *Validation \& Qualification**
* Oversee Process validation Equipment qualification (IQ/OQ/PQ) Sterilization validation
* Handle Internal audits External audits (Notified Body / FDA / Customers) Ensure audit readiness
* Ensure compliance with CE marking requirements Technical documentation Clinical evaluation Pay: ₹60,000\.00 \- ₹65,000\.00 per year
Job Overview
Job type Full-time
Work mode On-site
Location Gurugram
Posted 1d ago
Source Indeed