Lambert Michael Email

Lambert Michael Skills

• Head of Production according to German AMWHV
• Qualified Person (QP) according German AMG
• Project Manager / Authorized Person for Biological Safety GenTSV
• planning & installation of large scale fermentation plants acc. GMP
• budget responsibility / head of cost center
• personnel management (up to 20 employees)
• creation/check/release of GMP documents (e. g. SOPs)
• validation and qualification protocols and reports
• Change control / Change request / QAB / OOS / CAPA
• risk analysis (FMEA, Ishikawa)
• authority inspections (e. g. RP, BfArM, FDA)
• highly active pharmaceutical ingredients (hAPIs)
• gene technological plants (S2) and clean room classes A-D
• GenTG/GenTSV/BiostoffV
• MPG/Guideline 98-79 EG (IVD)
• TVO/HACCP
• lean 5S ("Best in class") / Kaizen / Kanban
• Member of German QP Association
• Member of European QP Association
• Patent System / Intellecual Properties
• intercultural Asia and US training
• regular QP training courses
• Malik Management System
• Microsoft Office 2007, MS Project, Share Point, Lotus Notes, SAP
• Siemens WinCC (system control), BioPAT MFCS/win3.0, MFCS/DA
• Trendows, LIMS, DHC Vision
• ISO 9001 / ISO 14001
• Contract Manufacturing
• Tech Transfer
• GMP-Compliance
• CFR 21 Parts 210/211, 11, 820
• CAPA
• GMP
• Biotechnologie
• Pharmaindustrie
• Forschung und Entwicklung
• Qualitätsmanagementsystem
• Änderungskontrolle
• Lead Auditor APIs u FDF
• Current ICH, WHO, EU GMP Guidelines
• internal customer audits
• Supplier Audits, Due Diligence, Mock Audits
• GMP, GDP, GLP
• Lead Auditor API, FDF, Logistics
• GMP training courses
• Self Inspections
• Logistics
• Head of Production
• Eu Gmp Leitfaden Incl. Annex 16
• GDP
• OOS
• Authority Inspections E. G. Rp
• Eu Gmp Leitfaden Incl
• Member of German Qp
• Current Ich
• Personnel Management Up to 20 Employees
• Highly Active Pharmaceutical Ingredients Hapis
• MS Project
• Head of Cost Center
• Lead Auditor Api
• Microsoft Office 2007
• Member of European Qp
• Dhc
• Gmp Compliance
• ISO 14001
• Kaizen
• Change Request
• Internal and External
• Risk Analysis Fmea
• Mfcs/Da
• Patent System
• Biopat Mfcs/Win3.0
• Trendows
• Change Control
• Leadership
• LIMS
• Planning and Installation
• Change
• Qualified Person Qp According German Amg
• Fdf
• SAP
• Gene Technological
• Cfr 21 Parts 210/211
• Marketing
• Eu Gmp Guidelines
• Ich Q7a
• Personnel Management
• Share Point
• Authority Inspections
• Planning and Installation of Large Scale Fermentation Plants Acc. Gmp
• ISO 9001
• Mpg/Guideline 98 79 Eg Ivd
• Strategic Planning
• FDA
• Regular Qp Training
• Ishikawa
• Lean 5s "Best in Class"
• Budget Responsibility
• Mpg/Guideline 98 79 Eg
• Siemens Wincc System Control
• Qualified Person Qp
• Validation
• Intercultural Asia
• Creation/Check/Release of Gmp Documents E. G. Sops
• Authorized Person for Biological Safety Gentsv
• Lotus Notes
• Project Manager
• Intellecual Properties
• Dhc Vision
• Internal and External Customer and Supplier Audits
• Management
• GLP
• Forschung Und
• Creation/Check/Release
• Siemens Wincc System
• Supplier Audits
• Due Diligence
• Kanban
• Highly Active
• Bfarm
• Mock Audits
• Qab
• Qualified Person According German Amg
• Creation/Checkelease of GMP Documents
• Risk Analysis
• Highly Active Pharmaceutical Ingredients
• Creation/Check/Release of GMP Documents