Improver

Diana Yosufov Hashper

Regulatory Affairs Manager at Bio-Technology General (a Ferring Company)

Israel

Wide experience in Quality Assurance in Pharmaceutical and Medical device industries.
Experienced in working in cleanrooms and specialized in aseptic processes & environmental control. Performing Internal and External Audits, Accompanying Regulatory inspections, Management of CAPA ,Non-Conformances and Change control records. Performing and approving equipment, utilities , facilities and process validations. Writing and Review of Documents such as Protocols, Validation reports, SOP's. Management of Suppliers ,raw materials and packaging materials. R&D Quality Representative.
Working according to cGMP, USP, EP and ISO guidelines and clean rooms environment

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Experience:

• Quality Assurance Manager (Mileutis Ltd.)
• GMP & Validation Associate, Quality Assurance (Bio-Technology General)
• Senior Quality Assurance Associate (InSight Biopharmaceutical LTD)
• Compliance Associate ,Quality Assurance (Bio-Technology General)
• Regulatory Affairs Manager (Bio-Technology General (a Ferring Company))

Skills: