Consultant Assurance Qualité Pharma Hispanophone

About the role

Capgemini Engineering is seeking a Spanish‑speaking Pharma Quality Assurance Consultant to support its pharmaceutical clients. The role involves ensuring product quality, compliance with regulatory standards, and effective data management across multiple departments.

Key responsibilities

• Participate in the preparation and execution of Product Quality Reviews (PQR) and Annual Product Reviews (APR).
• Collect, consolidate and analyse quality data from production, control and regulatory teams.
• Monitor quality indicators, perform trend analysis and report findings.
• Process and analyse data using Excel.
• Draft and update quality reports and documentation.
• Support the management of deviations, complaints, change controls and CAPA plans.
• Ensure adherence to GMP/cGMP, GDP, data‑integrity and overall compliance requirements.
• Collaborate closely with Production, Quality Control, Regulatory Affairs and other support functions.

Required profile

• Master’s level degree (Bac+5) in Pharmacy, Chemistry, Biology or Life Sciences.
• 3‑5 years of experience in the pharmaceutical industry, preferably in Quality Assurance.
• Strong knowledge of GMP/BPF, pharmaceutical manufacturing processes and dosage‑form production.
• Experience in collecting, consolidating and analysing quality data.
• Proficiency with Excel for data handling and analysis.
• Understanding of quality processes such as deviations, CAPA, change control and complaints.
• Familiarity with GMP/cGMP, GDP, data‑integrity and compliance standards.

Required skills

• Excel
• GMP
• cGMP
• GDP
• Data Integrity
• Quality data analysis