Quality Assurance Specialist

About the role

The Quality Assurance Specialist will lead and coordinate the implementation and maintenance of quality systems for our manufacturing site in Goa. This role ensures compliance with global standards, regulatory requirements, and internal procedures across all aspects of product quality and safety.

Key responsibilities

• Manage the overall Quality System, including Product Quality Reviews, Change Controls, Deviation, CAPA, and Market Complaint investigations.
• Act as the site coordinator for Sanofi Global Standards, SOPs, and GxP document approvals.
• Oversee validation activities for processes, cleaning, transport, and computerized systems, as well as utilities and purified water systems.
• Lead training programs, including cGMP and HSE training, and maintain the training system.
• Perform nitrosamine assessments, ICH Q3D compliance, and data integrity reviews.
• Support batch release, in‑process quality checks, sampling, and line clearance activities.
• Maintain the Site Master File, calibration documentation, user access controls, and document archival.
• Coordinate self‑inspections, audit trail reviews, and continuous improvement initiatives.

Required profile

• Strong background in pharmaceutical quality assurance and regulatory compliance.
• Experience managing comprehensive quality systems and leading cross‑functional teams.
• Ability to interpret and apply global standards, SOPs, and GxP requirements.
• Excellent analytical and problem‑solving skills with a focus on continuous improvement.

Required skills

• Nitrosamine assessment
• ICH Q3D compliance
• CAPA management
• Validation of processes, cleaning, transport and computerized systems
• GxP documentation and batch record review
• cGMP training and implementation
• Data integrity assessment
• Calibration document review
• User access management
• Analytical method creation and audit trail review