Quality Control (Reagents)

BioSystems Diagnostics Pvt. Ltd; Chennai District; On-site; INR 300,000 - 600,000; Full time

Job summary

BioSystems Diagnostics Pvt. Ltd in Chennai is seeking a Quality Control Specialist to oversee incoming inspection and quality testing of IVD products. The ideal candidate will maintain quality documentation and ensure compliance with ISO 13485 and GLP standards.

Responsibilities include investigating product complaints and coordinating with production and QA teams. Strong knowledge of diagnostic assays and quality management practices are required.

Qualifications

• Knowledge of IVD products, diagnostic assays, and laboratory techniques.
• Familiarity with quality management systems and documentation practices.
• Strong analytical, problem-solving, and communication skills.

Responsibilities

• Perform Incoming Inspection of RM, PM and Quality Control testing of IVD products.
• Maintain QC documentation, records, and test reports while ensuring compliance with ISO 13485.
• Investigate product complaints, non-conformities and support CAPA activities.
• Coordinate with Production and QA teams.

Skills

Knowledge of IVD products

Analytical skills

Problem-solving skills

Communication skills

Job description

Key Responsibilities:

• Perform Incoming Inspection of RM, PM and Quality Control testing of IVD products.
• Maintain QC documentation, records, and test reports and Ensure compliance with ISO 13485, GLP and regulatory requirements.
• Investigate product complaints, non-conformities and support CAPA activities.
• Coordinate with Production and QA teams.

Requirements

• Knowledge of IVD products, diagnostic assays, and laboratory techniques
• Familiarity with quality management systems and documentation practices
• Strong analytical, problem-solving, and communication skills