דרושים טבע תעשיות פרמצבטיות

Manage and lead RA team.
Key Responsibilities / Deliverables:
Manage and lead RA team in preparing submissions for US, EU and CA markets and responding to deficiency letters.
Review submission files and deficiency letter responses.
Provide regulatory guidance, support and resolve issues raised during product development and review period.
Ensure teams regulatory activities are carried out and tracked on a timely manner.
Support pre-launch activities.

Mission and roles:
Support the review of 3rd party Batch Manufacturing Records and analytical data.
Support review of stability studies.
Data consolidation and organization to enable statistical analysis.
Support data entry into different data base platforms.
Support statistical and trend analysis.
Support the preparation of regulatory documentation prior and post submission /approval.
Support with review, harmonization and alignment of specifications documents for commercial and pipeline products prior and post submission /approval.
Facilitate collaboration with other functions and individuals in Teva's Bio Operation teams.
Participate and contribute to cross-functional meetings.
Part time position in our Tel Aviv HQ.

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.

Manage a team of team leaders in establishing and maintaining quality at the lab in accordance with labs SOPs, regulatory guidelines and cGMP compliance requirements.
Responsible for cross-departmental communication to meet KPIs and management demands.
Professional support of the team leaders in daily troubleshooting and solving problems that may come up in the day to day operation of the laboratory.
Professional on-going training of laboratory employees.
Responsible for maintaining work standardization in the laboratory.
Manage and maintain laboratory SOPs. Update when deemed necessary.
Assistance in preparing the laboratory for internal and external audits, to ensure compliance with Teva's global standards, regulatory guidelines and cGMP requirements.
Assist with document management, validations, verifications, filing and organization of paperwork.
keeping the laboratory organized