Contact person for the Israel Health and Regulatory Authorities
Accompanies Israeli Ministry of Health regulatory inspections and responsible for providing inspectors with all relevant data
Oversees the implementation of follow up and corrective actions committed to as a result of these external audits and the evaluation of effectiveness of corrections
Oversees the product batch release process
Oversees the implementation of Standard Operating Procedures relating to the release of products and compliance with the requirements of Good Manufacturing Practice (cGMP)
Where deviations occur relating to the release process, ensures that they are fully documented and investigated, reported to Quality Assurance in a timely manner, as well as suggesting corrective action and preventive actions for future, where appropriate
Stands as contact person for customers (within and outside Teva) for batch release purposes
Ensure that testing and release or rejection of packaging materials and raw materials is performed according to approved standard operating procedures and test methods
Evaluation of batch release after temperature excursion during shipment
Ensures the documentation (batch files) is handled according to the relevant approved procedures
Responsible for pre and post-printed approval of new editions of printed packaged materials
Responsible for controlled drugs, including ordering, using for production and reporting to the Israeli Ministry of Health
Responsible for authorization importation of materials
Responsible for Pharmacist permit for costumer complaint samples & lab analysis materials import - Mslul
Manages and executes the regulations of the Israeli Ministry of Health with regards to first batches for the Israeli market
We at Teva believe in equal employment opportunity, needed adjustments and adaptions to the work environment will be considered