Lucas Lima

Lucas Lima is a senior pharmaceutical quality professional with more than 16 years of experience in GMP-regulated environments, working across quality assurance, quality control, qualification, validation, biotechnology, vaccines, antibiotics, injectables, and solid dosage forms. His career has progressed from hands-on validation and QA roles to senior quality leadership, including serving as Head of Quality.

As a Senior Quality Consultant at Zamann Pharma Support GmbH, Lucas supports pharmaceutical organizations with strategic quality challenges, from routine GMP operations to complex transformation and remediation projects. His work combines quality-system improvement, inspection readiness, validation, organizational development, and leadership.

Previously, as Head of Quality at Fundação Butantan, Lucas led Quality Assurance, Validation, and Quality Control activities and managed multiple Quality Managers. He also supported regulatory interactions and quality activities related to vaccine development, including the COVID-19 vaccine program. His leadership included helping build and develop a Quality organization that grew from around 100 employees to more than 350, while strengthening the Quality Management System and modernizing laboratory operations.

Lucas also brings deep operational experience in computerized system validation, equipment qualification, IQ/OQ/PQ, cleaning validation, risk assessment, audits, deviation management, change control, and inspection preparation. Earlier in his career at Sanofi, he worked directly with validation of equipment, computerized systems, HVAC, water systems, and manufacturing utilities, while supporting internal and regulatory audits.

His core areas of expertise include:

• Quality Team Building & Leadership Development
• Quality Management Systems (QMS)
• GMP Compliance & Inspection Readiness
• Computerized System Validation (CSV)
• Qualification & Validation Lifecycle
• Deviation, CAPA & Change Control
• Quality System Remediation & Maturity Improvement
• Resource, Budget & Operational Optimization

Lucas holds a degree in Pharmacy and postgraduate qualifications in Quality Management and Auditing in Industrial Processes, supporting his combination of technical, operational, and leadership expertise.

At Pharmuni, Lucas brings practical senior-level quality experience into learning and professional development, helping learners understand how GMP quality systems, validation, inspection readiness, and quality leadership work in real pharmaceutical organizations.