Project Management
in Life science
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Quality & Engineering professional, Bich Van Ho is an expert in management of multisite projects at world level Over 25 years’ experience in pharmaceuticals, biotechnology and chemicals, with comprehensive expertise: devising and implementing harmonized global strategies for cGMP manufacturing Operations, R&D laboratories, Pilot plant - API Drug Substance Bulk Drug Product and Finished Product Injectables and in charge of multi- projects for Equipment HVAC, Utilities, Equipment Facilities, Processes; in particular for delivering infrastructures from project initiation to operational readiness according to budget, scope and on-time deliverables and for routine activities life cycle operation activities.
Our field of expertise are HVAC Clean room classification Design strategy, Commissioning, Qualification and Validation, Compliance with GMP standards, improving Quality Engineering processes in preparation for Swissmedic inspections, FDA and European authority audits, involvement in projects for a range of infrastructures, technical transfer, team management. Our role makes us the interface between group divisions, with strategic and operational ability, and a sense of organization, pragmatism and analysis, we wish to take commit to a company as supporting management and make the most of our ability to relate easily with people, to coordinate and to respond creatively with ease to challenging situations.
We are offering the following support services:
- Multi- projects for Equipment HVAC, Utilities, Facilities
- from project initiation to operational readiness and life cycle operations activities
- HVAC Clean room classification Design strategy, Commissioning, Qualification and Validation
- Compliance with GMP standards, improving Quality Engineering processes
- Inspection readiness with heath authorities Swissmedic, FDA and European authorities, audits
- Technical support for Equipment procurement, vendor selection
- Manage cross functional interfaces
- BioEngineering/MSAT/Site Engineering/Quality Assurance/external stakeholders
- Implementing strategies for Design of facilities infrastructure room area classification
- Supervising, coaching, training, supporting staff,departments, contractors
- Maintenance Engineering HVAC UTIL
- Construction Commissioning Qualification activities
- Transfer of systems Buildings to Quality Systems and Operations department
- Harmonization Standards Internal policies and ISPE Guidelines