Itzik Hagigi Email & Phone Number

Project management for new and existing critical equipment according to global standards and regulation compliance.

Engineering, Maintenance & Validation ManagerDetermining engineering, validation and maintenance procedures according to the business contingency plan, validation master plan and all applicable regulatory standards. Presenting the engineering and validation status to any required regulatory authority.

Revadim, Hadarom (South) District, Israel

Establishment of the engineering department, determining engineering, validation and maintenance procedures according to the business contingency plan and all applicable regulatory standards. Recruiting the first base for the engineering, validation & maintenance department. Presenting the engineering and validation status to any required regulatory authority (IMC – GAP, IMC GMP and IMOH GMP).

Tel Hashomer, Tel Aviv District, Israel

Lead the Validation Team for cleaning, critical Equipment and System used for production, packaging and distribution in Omrix PFI . Setting and implementing of the Validation standards, keeping the plant validation Status and presentation the validation status to any required regulatory authority.

Jerusalem Area, Israel

Technical Support Team leadProject management for new and existing critical equipment according to global standards & Regulation compliance. Leader of the Technical Support Team for critical Equipment used for production and packaging of OSD & inhalers. Setting and implementing standards for the plant equipment's as well as for contractors, machine manufacturers and service providers in Israel and abroad.

Jerusalem

Project management for new and existing critical equipment according to global standards & Regulation compliance.Technical Support for critical Equipment used for production and packaging of OSD & inhalers. Setting and implementing standards for the plant equipment's as well as for contractors, machine manufacturers and service providers in Israel and abroad.

Head of the Quality Assurance operations for critical Systems & Equipment used for production and packaging of inhalers. Setting and implementing standards for the plant Quality system as well as for contractors, machine manufacturers and service providers in Israel and abroad. Project management for new and existing critical systems and equipment according to global standards & Regulation compliance.

Israel

Managing compliance processes of systems & equipment according to global standards & regulation compliance. Writing and approving qualification protocol (e.g. IQ, OQ, PQ, SAT, FAT etc.). Training and qualifications of other validation engineers.

Management, upgrade & development of steam, compressed air, vacuum systems and both production & packaging equipment. Performing qualification studies for equipment (e.g. IQ, OQ, PQ, SAT, FAT etc.). providing engineering services for other departments . (e.g. T&SA, ICU, Supply Chain, production etc.)

Israel

Israel