Senior QA Assurance Analyst

About the role

Baxter is hiring a Senior QA Assurance Analyst in São Paulo (Interlagos, Southern Zone), a fully onsite position. The role supports investigations into product complaints, recalls and deviations, reviews investigation reports, works with production, regulatory affairs, quality systems and supply chain, and helps keep quality, safety, delivery and productivity metrics met.

Key responsibilities

• Support investigations of NCRs, CAPAs, escalations, product complaints and market recalls, and review and approve them
• Ensure compliance with global Quality, Safety, Delivery and Productivity metrics
• Investigate deviations, market complaints and recalls, and support technical investigations of customer complaints, proposing corrective actions to prevent recurrence
• Prepare procedures based on internal policies, current regulations and global standards, and ensure quality indicators are reliable
• Analyse trends, identify gaps and improvement opportunities, and track corrective and preventive actions
• Carry out and evaluate routine inspections in production and support areas, and follow up open actions within deadlines

Required profile

• Complete university degree in Pharmacy
• Postgraduate studies in Quality or related fields desirable
• Experience in pharmaceutical industry, preferably in Quality Operations or Production
• Knowledge of pharmaceutical quality legislation and experience investigating deviations and market complaints
• Advanced English; Spanish desirable

Required skills

• Risk analysis experience
• Differentiators: knowledge of Trackwise and JDE systems, and electronic batch records