לוח משרות דרושים רפואה ופארמה

we are currently hiring a
Quality Assurance and Qualified Person Lead (m/f/x)
(fulltime/ permanent)
You will perform all activities as Qualified Person and Quality Manager for the Israeli affiliate of CSL Behring, which is in an establishment phase.
You will implement and maintain the QMS of CSL Behring Israel.
Main Responsibilities and Accountabilities:
Release/ rejection / partial rejection of lots to the Israeli market according to MOH regulations, GMP and GDP requirements
Supervise the rework/repackaging of products
Handle returns and recalls
Prepare and lead MOH audits, assistance and participation in quality audits, either internal or external
Create and update SOPs
Conduct GMP and GDP trainings
Condut supplier audits and qualification
Prepare and present periodic Quality Management Reviews

We are looking for a Clinical Research Associate (CRA) to join our Compliance and Regulatory Affairs (RA) team. Compliance and RA team is responsible for the companys clinical and regulatory activities, quality management systems, and for ensuring compliance with applicable standards.

The team plays a central role in both pre-market and post-market activities. The CRA will play an important role, working with clinical sites, ensuring successful management of clinical activities, and performing assigned monitoring activities throughout the clinical trial lifecycle.



Your responsibilities will include:

Managing global clinical trials at multiple clinical sites, taking part in planning clinical studies, defining clinical protocols, and supporting regulatory documentation.
Collaborating with multiple stakeholders to ensure successful, rigorous, and timely studies.
Proactively managing clinical study processes and monitoring activities. Overseeing and supervising clinical operations to ensure activities are carried in accordance with applicable regulatory requirements and guidelines.
Maintaining strong relationships with external experts to ensure effective execution of clinical studies and research projects.
Taking part in defining and approving clinical study protocols and plans, IRB submission documents, CRFs, and clinical study reports.
Facilitating team training per study protocols and supporting regulatory submission and documentation.

We are looking for a Site Technology Administrator who will be responsible for leveraging the resources and capabilities of the IT organization to enable business success across sites and regions while exemplifying the mission, values, and goals of the Enterprise Technology Office.


The Site Technology Administrator actively partners with our business units and fellow Enterprise Technology departments across their site and region of responsibility emphasizing quality and timely response.
This is a full-time, exempt, office-based position, fully on-site based in our Haifa, Israel office location.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Manage the day-to-day functions of the site technology and local IT hardware inventory.
Identify and track site issues and risks.
Participate in site-related expansions moves, and projects.
Foster and maintain relationships by engaging business leaders, teams, and end-users.
Provide support and solutions to all personnel on-site and at their remote locations.
Promote an environment that encourages information sharing and focuses on prompt and effective end-user issue resolution.
Facilitate employee onboarding and off-boarding.
Instruct users according to internal training, IT General Controls (ITGCs) and standard operating procedures (SOPs).
Monitor ticket queues to ensure incidents are being handled on a timely basis by the service desk, identify trends and escalations when needed, prioritize, communicate status, and work through to resolution in person, over the phone, and by utilizing remote tools when necessary.
Report the status of tickets to the Enterprise Technology Leadership Team.
Manage local technology vendors, and ensure resolution and SLAs are achieved by managed service providers.
Serve as a local contact for technology service providers such as internet service providers, mobile phone and network providers, and technology-related hardware providers at the site.
Work independently to complete assigned individual projects, tasks, or other ad hoc duties as assigned.