Quality Assurance Officer

Job Title: Quality Assurance Executive
Location: Mumbai - Vile Parle

Experience: Minimum 5 years of experience in Quality Assurance

Job Description:

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
• Strong 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