דרושים » מדעים מדוייקים » Quality and Compliance Engineering SME

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Location: Petah Tikva
Required Quality and Compliance Engineering SME.
Global Engineering (GE) Quality and Compliance SME will serve as Tevas focal point for quality and compliance aspects related to engineering processes, manufacturing equipment and systems.
In corporation with Global Quality and EHS will lead the development and implementation of Tevas policies and standards related to manufacturing equipment and systems throughout their lifecycle.
The Quality and Compliance SME will interface with the different manufacturing segments and sites as well as GE Segments BP, supporting them in the implementation of Tevas engineering policies and standards.
Lead and participate in quality and compliance sites audits related to engineering aspects.
Requirements:
Education: B.A / Bsc. degree in Engineering (Mechanical / Electrical / Chemical / Industrial) and / or M.A / Msc. degree in Engineering Must.
Experience in the pharmaceutical/chemical industry Must.
10+ year within quality or engineering support and management functions (facility quality assurance, calibration / metrology, validation / qualification) within FDA, EU commission, ISO regulated industries Must.
Knowledgeable and good familiarity with FDA/CFR Title 21 Parts 11, 210-211,820, cGMP/GDP, ISO (14644, 9001, 13485, 17025) and other various regulatory standards - Must.
Experience in global, large, complex, multi-level organizational interfaces Must.
Excellent understanding of global function role and the nterrelationships with the local manufacturing sites Must.
Global, multinational experience.
Fluent in English. Additional languages advantag.
 
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