Junior QA/RA Executive Job at NeoDx

NeoDx Biotech Labs Pvt. Ltd., a leading ISO 13485:2016 certified molecular diagnostics company, is hiring a Junior QA/RA Executive in Bengaluru, Karnataka. This is an exciting opportunity for biotechnology and life sciences graduates looking to grow in the Quality Assurance and Regulatory Affairs field, especially within IVD, medical devices, and biotech industries.

The role offers hands-on experience in QMS, regulatory documentation (CDSCO, CE-IVDR, QSR 21 CFR), audits, and compliance—essential skills for building a strong regulatory career.

Key Responsibilities

As a Junior QA/RA Executive at NeoDx, you will:

• Monitor, review, and approve production QC activities and documentation in QMS Portal (SAP).
• Review raw materials incoming inspection records (SAP).
• Conduct final QC performance checks during kit assembly for lot release.
• Implement QMS changes, update SOPs and processes.
• Document OOS, NC, risk observations, and maintain logs for production, equipment, and infrastructure.
• Support labeling compliance, QC improvements, and product registration (national & international).
• Assist during internal and external audits.
• Collect and analyze PMS, CAPA, and complaint data.

Qualifications & Requirements

• Education: Bachelor’s or Master’s in Biotechnology or any Life Sciences background.
• Experience: 1–2 years in QA/RA, preferably in IVD, biotech, or medical devices.
• Technical Skills:
  • Knowledge of ISO 13485, ISO 14971 standards.
  • Proficiency in SOP/documentation and QMS management.
  • Exposure to eQMS or G-Suite based QMS (preferred).
• Soft Skills: Strong communication, organizational skills, time management, and regulatory knowledge.

Benefits of Joining NeoDx

• Opportunity to work in a fast-growing molecular diagnostics company.
• Hands-on exposure to IVD and medical device regulatory compliance.
• Skill development in audits, QMS, product registration, and risk management.
• Collaborative work culture in Bengaluru’s biotech hub (Hebbagodi, near Biocon).

Application Process

Interested candidates should apply through the official NeoDx Google Form:
👉 Apply Here