Quality Assurance Officer

Sona Star Healthcare; Mumbai; Sur place; INR 600 000 - 1 200 000; Plein temps

Résumé du poste

Sonastar Healthcare LLP in Mumbai (Vile Parle) seeks a Quality Assurance Executive with 5+ years of QA experience and strong knowledge of ISO standards to ensure compliance with quality systems and regulatory requirements.

You will implement and monitor QMS, support external audits and inspections, manage documentation, and drive continuous improvement across production, procurement and related departments.

Qualifications

• Minimum 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.

Responsabilités

• 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.
• 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.

Connaissances

Quality Assurance

ISO standards

CAPA

Regulatory compliance

QMS

Formation

BS/MS Biotechnology

Outils

MS Office

Quality documentation systems

Description du poste

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 : [phone]

Sonastar Healthcare LLP

https://sonastarhealthcare.com