JOB DESCRIPTION | QC EXECUTIVE
Astam Diagnostics Pvt LTD
In Vitro Diagnostics (IVD) & Medical Devices (MD) Plant
Department
Quality Control
Reports To
QC Team Lead / QC Manager
Location
Manufacturing Plant
Employment Type
Full-Time, Permanent
Regulatory Scope
IVD (IVDR / CDSCO MD Rules) & Medical Devices (MDR / ISO 13485)
Experience Required
3–6 years in QC in IVD or Medical Device manufacturing
Education
B.Sc. / M.Sc. / B.Tech in relevant discipline; additional QMS certifications preferred
Salary
30-40K negotiable
Role Summary
The QC Executive is a hands-on technical role responsible for executing day-to-day quality control activities across raw material, in-process, and finished product testing at the IVD and Medical Devices manufacturing plant. The incumbent will ensure testing is performed accurately and in accordance with approved SOPs, regulatory requirements (ISO 13485, CDSCO MD Rules 2017), and internal quality standards, supporting the delivery of safe and compliant products.

Key Responsibilities
1. Testing & Analysis
• Perform physical, chemical,



microbiological, and functional testing of raw materials, in-process samples, and finished products as per approved specifications and SOPs.
• Execute ELISA, PCR/qPCR, immunoassay, colorimetry, spectrophotometry, and microbiological assays for IVD product testing.
• Operate and maintain laboratory instruments including spectrophotometers, plate readers, PCR machines, pH meters, and analytical balances.
• Record all test data accurately in laboratory notebooks, worksheets, and LIMS/ERP systems in real time.
• Ensure proper labelling, storage, and traceability of test samples, reference standards, and reagents.
2. Documentation & Compliance
• Prepare and review test reports, Certificates of Analysis (CoAs), and batch release documentation.
• Follow and maintain Positive Documentation Practices (GDP) at all times.
• Maintain up-to-date laboratory records including calibration logs, equipment usage logs, and sample regis

📌 Quality Control Executive (New Delhi)
🏢 Astam Diagno
📍 New Delhi