Primary purpose and function of this position:
In Charge of quality aspects and compliance in CMC Biosimilar Israel Quality R D
General duties and responsibilities:
Implementation of Standard Operating Procedures relating to CMC Biosimilar activities and compliance with the relevant requirements of quality systems according to the research and development stage
Ensure the continuous improvement in the quality of CMC Biosimilar activities
Approval of equipment and systems validation and qualification protocols and reports
Approves change controls
Manages and approve Standard Operating procedures, Work Instructions, protocols, reports and other controlled documents
Management of deviation and CAPA
Perform internal audits and accompanies external audits as required
Develop, implement and optimize quality initiatives in alignment with Teva vision and mission statements
Requirements: B.Sc. in biology / biotechnology or other scientific or engineering field
Knowledge of cGMP requirements and quality management systems
Fluent English and Hebrew (reading, writing and speaking)??
Detail oriented, broad thinker, independent, can-do attitude, data integration capabilities, meticulous, service oriented, proactive, initiative, good writing skills, focus efforts where matters, separate the wheat from the chaff, efficient, in depth reviewer.
המשרה מיועדת לנשים ולגברים כאחד.