Nicolae Theodor Moisidis

About Nicolae Theodor Moisidis

CALifornia Consulting Engineering and Technology…

Experience

1. Consultant

   Impax Laboratories

   Sep 2000 — Present · 30831 Huntington Ave, TW

   Develop of Specs, Commiss, Validation and Final Package Preparat for the Taiwan Manufacturing Plant in Jhunan Science Park, Miao Li for the following : Air Handling Units, Manuf Area, Warehouse, CDA Generation and Distribution, Building Magment System, Room Monit System; Commiss and Qualific for Reloc of Bldg. 5 Samples Booth, Valid of Oxy/Doxy Solvent Tank; Qualific of Karl Fisher Filtrator, Drum Lift, PMA-150 Spray System and Clean Rooms; Qualific of Vibro-screen IP5305 Wurster, Modific of the Glatt 4 WIP System; Study of Sweco Sifter/PIAB System for Tamsulosin; Validation of Size 2 Pellet change parts on the Matic 90 and New D24 Pots; Validat of the New Hazardous Materials Storage Area and Sample Rooms; Authoring of a Computerized System SOP; Qualification of Replacement PIAB vacuum Pump for the Blender; Qualific of Bldg. 2 LCI Extruder, Phase 1b Facility/HVAC/ CDA/RMS (URS/FRS and IOP/Q Document Revision); Qualific of the: CIP and COP Skid, Process Support Systems, Mixer, MG2 Planeta Encapsulator for Size 2 Pellets with 7.2 mm Dosing and Size 1 Powder, Wurster Bowl, New Fitzmill VHP-D6A Machines, SuperCoater Equipment, Solvent Tanks Type 2 Vessels, Modified Blade on the Hobart Mixer, Project Management, Glatt 1 vs. Glatt 3 Equivalency; Qualific of Size 0 and 00 Capsules Transport Change Parts and 7.2 mm (min/max) dosing Pellet Fill, FENO Equip, Size 1 Bushings on the MG2 Futura Encapsulator, Fitzmill VHP-DSA Machines, Fette 1200i Fill CAMS 14mm/16mm/18mm, Clean and Cold Rooms, Fette 2200i Fill, Manesty Unipress Control Upgrade, Glatt 3 and 4 Printer, Nilfisk Vacuum, Safeline Metal Detector; Eng Study for the Fette 2200i Air Sorting 8mm/10mm/and 12mm cams; FAT and Partial Qualific of the Drum Lift and Lock MET 30+; Qualific of Fette 2200i Air Sorter Tower; Engineering Study and Qualification for B-Turret I and II; Qualification of the Fette 1200i New Pharma Technology Tablet Deduster/Lock metal Detector Unit and Single Chamber Fill-O-Matic Feeder and HVAC System;

Skills

• Automation
• Iso 13485
• Pharmaceutical Industry
• Sop
• Fda
• Continuous Improvement
• Change Control
• Clinical Trials
• Process Optimization
• Commissioning
• Project Management
• Strategic Planning
• Cross-Functional Team Leadership
• Biotechnology
• Process Engineering
• Instrumentation
• Regulatory Affairs
• Lifesciences
• Quality Control
• Gmp
• Clinical Development
• Quality Assurance
• Validation
• Laboratory
• Engineering
• Biopharmaceuticals
• Plc
• Manufacturing
• Hardware Diagnostics
• Product Development
• Technology Transfer
• Process Control
• Computer System Validation
• Lean Manufacturing
• Root Cause Analysis
• Pharmaceutics
• Medical Devices
• Capa
• Quality System
• V&V