Leonel Monteiro Da Silva Email & Phone Number

Porto, PT

Bad Homburg, Hessen, DE

Committed to Life & Striving for Quality Excellence while leading, coordinating and supporting a group of 8 global pharma and medical devices manufacturing sites within Europe and Latin America.

Bad Homburg, Hessen, DE

Striving for Quality Excellence while leading, coordinating and supporting a group of up to 10 global pharma and medical devices manufacturing sites within Europe and Asia.Main Achievements: - Successfully implemented a Quality Culture Excellence Program to increase Q awareness throughout Quality and Operations.- Successfully implemented the harmonization.

Bad Homburg, Hessen, DE

Striving for Quality Excellence while leading, coordinating and supporting a group of up to 12 global pharma and medical devices manufacturing sites within Europe and Asia.Main Achievements: - Successfully implemented a Quality Culture Excellence Program to increase Q awareness throughout Quality and Operations.- Successfully implemented the harmonization.

Bad Homburg, Hessen, DE

Managed and led a sterile manufacturing site of 550+ people, responsible for Production, Quality, HR, Supply Chain and IT with close collaboration with local and international markets.Main Achievements: - Successfully implemented a remediation plan aiming for a quality culture turnaround and a comprehensive operational transformation to ensure.

Bad Homburg, Hessen, DE

Reported Directly to VP QA Global Operations being responsible for the QA support, compliance and coordination of 4 manufacturing plants within Europe and South Africa.

Bad Homburg, Hessen, DE

Qualified Person regarding aseptically filled dry powders for Local and International markets.Batch certification according to applicable Marketing Authorization and concerning GMP guidelines.

Bad Homburg, Hessen, DE

Quality Assurance head for 4 manufacturing units with several pharmaceutical technologies from aseptic filling, TS to oral dosage forms. Direct report to Corporate Operations QA. Managing a team of 20 plus elements.Main Achievements:- Effectively re-designed the QMS in order to face the transition from a local supplying plant to a Global supplying plant..

Bad Homburg, Hessen, DE

Within the Quality Unit manages the GMP Compliance Department, encompassing the following duties and responsibilities: > cGMP Compliance Assessment: evaluate processes compliance according to applicable cGMPs regarding several technologies from aseptic filling, TS to oral dosage forms for Local and International markets;> Suppliers Qualification Mgmt.

Bad Homburg, Hessen, DE

Within the Q-Unit:cGMP ComplianceSuppliers QualificationCAPA mgmtContinuous Improvement

Bad Homburg, Hessen, DE

Deviations and CAPA mgmtChange Control mgmtComplaints and recalls mgmtSuppliers Qualification mgmtcGMP TrainerAuditor

Qualified Person deputy. Managing a team of 6 elements.

Msc, Pharmaceutical Sciences

Certificate, Administração De Empresas

Executive Mba

Post-Graduate, Biomolecular Sciences

Pharmd, Pharmaceutical Sciences