דרושים טבע תעשיות פרמצבטיות

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.

Responsible for Teva api cGMP compliance by supporting the Teva api sites in the network: inspection readiness, execution and follow up of audits, investigations, risk assessments and maintaining Teva api Quality Management System.
Required to travel regularly; up to 50 % of the time.
Co-ordinate with the relevant SQHs around inspection readiness
Attends Regulatory Audits in the Teva api network as representative of Teva api Global Compliance.
Prepare and Review audit responses to Regulatory Audits of the Teva api sites and follow up.
Update and renew Teva api divisional policies as part of the Teva api Quality Management System (QMS)
Review investigations, Risk Assessments of Teva api sites
Continually improve and implement processes that will enhance the Teva api Quality Management system.
Develop metrics and targets that will assist Teva api sites to stay compliant.

Perform risk assessment of chemical toxicophores, impurities, and/or excipients, present in drugs under development and those in the market, either innovative or generic.
Write toxicological assessment reports and responses to regulatory agencies (i.e. response to FDA deficiency letters).
Represent the Chemical & Computational Toxicology group in internal as well as in external meetings.

Ensures data management activities and deliverables for area(s) of responsibility are completed in line with business requirements and company objectives.
Evaluates and approves service level agreements.
Oversees service providers to perform core data management functions including CRF, edit check development, eCOA, user acceptance testing, data cleaning, reviewing listings, and database locking procedures.
Evaluates and makes recommendations related to inter- and intra-departmental processes in order to identify and implement efficiencies and quality improvement measures.

As part of Tevas Global Nitrosamine Project Team, the Nitrosamines Investigation Lead plays an important role in the oversight of technical activities related to root-cause investigations associated with the management of nitrosamines.
This role will drive interactions across Teva sites and entities in the creation of an integrated Teva technical position on nitrosamine related issues.
The incumbent will ensure alignment amongst Teva sites, Segment and Global entities, including a common strategy for managing root cause investigations at Teva sites and CMOs.