Job Title: Quality Assurance Executive

Location: Mumbai - Vile Parle

Experience: Minimum 5 years of experience in Quality Assurance

:

We are looking for a Quality Assurance Executive with sound knowledge of ISO standards and to ensure compliance with quality systems, regulatory requirements, and continuous improvement in processes.

Key Responsibilities:

- Implement, maintain, and monitor Quality Management Systems (QMS) in line with ISO standards (ISO 9001 / ISO 13485 / ISO 22000, as applicable).
- Ensure compliance with CDSCO guidelines and regulatory requirements (preferable experience).
- Prepare, review, the quality manuals.
- Analyzing, and follow up on corrective and preventive actions (CAPA).
- Support external audits, regulatory inspections, and certifications.
- Ensure proper documentation, record control, and data integrity.




- Monitor quality parameters, investigate deviations, non-conformances, and customer complaints.
- Coordinate with production, procurement, and other departments to ensure quality compliance.
- Participate in risk assessment, change control, and continuous improvement activities.

Requirements:

- BS/MS Biotechnology
- 5 years of experience in Quality Assurance
- Robust working knowledge of ISO standards.
- CDSCO regulatory experience is highly preferred
- Proficient in MS Office and quality documentation systems.

Contact Person : HR Preetisha

Contact Number : +917977842973

Sonastar Healthcare LLP https://sonastarhealthcare.com

📌 Quality Assurance Officer (Mumbai)
🏢 SONA STAR HEALTHCARE
📍 Mumbai