Analista de Aseguramiento de la Calidad

About the role

Catalent is seeking a Quality Assurance Analyst to support its Loma Hermosa plant in Buenos Aires. The role involves ensuring product quality, regulatory compliance, and continuous improvement within a fast‑paced pharmaceutical manufacturing environment.

Key responsibilities

• Manage quality deviations, investigations, CAPAs and verify their effectiveness.
• Participate in complaint investigations, quality events and follow‑up of laboratory and maintenance investigations.
• Coordinate and approve reprocesses, reworks and resampling activities.
• Review and maintain quality documentation such as SOPs, batch records, certificates of analysis and archival files.
• Ensure adherence to cGMP, Catalent policies and relevant regulatory requirements.
• Perform on‑site Quality Assurance activities throughout the production process.

Required profile

• University degree in Pharmacy, Biochemistry or a related field.
• Previous experience in the pharmaceutical industry within Quality Control, Quality Assurance or related areas.
• Intermediate to advanced English proficiency.
• Strong knowledge of cGMP, 21 CFR 210/211, Part 11 and ICH guidelines.

Required skills

• Proficiency with MS Office applications.
• Hands‑on experience with cGMP practices.
• Familiarity with 21 CFR 210/211 regulatory requirements.
• Understanding of Part 11 electronic records compliance.
• Knowledge of ICH guidelines.

What we offer

• Opportunity to work with a global leader in drug development and delivery.
• Engagement in meaningful work that impacts patient health worldwide.
• Dynamic, collaborative environment focused on continuous improvement.