To ensure that all products are manufactured and released in compliance with regulatory, statutory, and quality requirements, maintaining a robust Quality Management System (QMS).

Key Responsibilities

Quality Management System (QMS)
Establish and maintain QMS as per:
ISO 13485
EU MDR (2017/745)
FDA (21 CFR Part 820 / QSR)

QA Oversight
Approve:
BMR/BPR
SOPs
Change controls
Ensure document control and traceability

QC Management
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

Audit Management
Handle:
Internal audits
External audits (Notified Body / FDA / Customers)
Ensure audit readiness

Regulatory Compliance
Ensure compliance with:
CE marking requirements
Technical documentation
Clinical evaluation

Pay: ₹60,000.00 - ₹65,000.00 per year

Work Location: In person

📌 Quality Assurance Analyst Sonipat
🏢 Krishna Chemicals
📍 Sonipat