Hamed Sorkhabi

Responsible for capital projects, project transfer, development of good engineering practices, site consolidations, consolidation of R&D equipment globally which includes inspection, relocation, installation, commissioning, calibration and qualification of equipment and leading and monitoring project activities within Gx R&D Global Operations for 12 sites located in India, Israel, Hungary, Germany, UK, Iceland, Chile, Argentina and USA.

Supervised R&D operation, processes and personnel in two major formulation sites. Lead equipment and facility Capital Engineering projects involved purchasing, installation and qualification of major pharmaceutical equipment such as large scale fluid bed dryers, encapsulators, tablet press, hot melt extruder, extruder/spheronizer, hot spinning disk, lyophelizer, micro fluidizer, blister packaging, shachet packaging as well as major facility modifications, expansion, renovation and site consolidations

Managed R&D operations in two major R&D sites in USA. Lead complex Engineering capital projects (equipment and facility) to complete purchasing, installation, modification and qualification of various pharmaceutical equipment such as fluid bed dryer, tablet press, coating pans, granulator, encapsulation, roller compactors, packing line and etc. as well as major facility upgrades, expansion and modifications.

Lead Engineering capital projects (equipment and facility) to complete purchasing, installation, modification and qualification of various pharmaceutical equipment such as fluid bed dryer, tablet press, coating pans, granulator, encapsulation, roller compactors, packing line and etc. Liaised between R&D and Engineering equipment/facility maintenance to ensure all issues faced in daily operations are resolved as quickly as possible with minimum down time for R&D operations.

Provided engineering support involving part design, equipment repair, relocation, calibration, re-qualification to enhance R&D operations and goal to submit an average of 10 FDA new drug submission each year. Lead Engineering capital projects including purchasing, installation, modification and qualification of various pharmaceutical equipment/instruments. Liaised between R&D and Engineering to ensure all issues faced during operation hours were resolved to ensure minimum down time for R&D operations.

Supported installation and qualification of various pharmaceutical equipment such as fluid bed, hydraulic inverter, spray dryer, fume hoods and classified scale, to ensure compliance with Quality Assurance, Safety, Engineering and external regulatory agencies such as FDA and HPFBI (Health Canada) Optimized and maintained Systems, Applications and Products in Data Processing (SAP) Supported the start-up for installation and operational qualification of special product facility for highly toxic compounds

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