Project Management

Pharmaceutical & Biotechnology projects management skills

  • Construction supervision, Design Review and Management
  • Work breakdown structure (WBS) development
  • Technical & Functional Programs & Plans Development
  • Workshop Drawing Approvals & related Design Qualification for Equipment & Facilities
  • Overall Project management including :
  • Cost & Invoicing Control & Management including :
  • Release of payments, related partial and final approval of works management
  • Project & Process Risk, Mitigation Alternatives & HSE Management (according to RAPA Approach)
  • Project Portfolio Management
  • (Project & Engineering) Document Management
  • Project Communication Management
  • Timeframe, Deadlines & Scheduling Management
  • Performances & Quality Management including Benchmarks
  • Human Resources Management
  • Workflow System, Suppliers & Contractors, using MS Project & dedicated Web-based Project Management (https://en.wikipedia.org/wiki/Comparison_of_project_management_software)
  • HSE plan & procedures development & ATEX management
  • Preparation of equipment, cleanrooms, and facility pre-purchase packages
  • Procurement, contract management and follow-up
  • Equipment delivery management
  • Equipment & systems installation supervision
  • Start-up & troubleshooting tests
  • Commissioning, FAT & SAT
  • Validation support including IQ, OQ, PQ, Cleaning Validation & Process Validation according updated FDA2011 & EMA2014 Guides
  • http://www.linkedin.com/pub/aziz-chraibi-phd-eng/b/a38/170

Pharma Bio Expert, your cGMP Regulation & Engineering Compliance Partner