לוח משרות דרושים רפואה ופארמה

In this role, you will be supporting Engineering and R&D departments as well as being involved in QA activities.

The QA engineer position is temporary for 2 years (project support).

Essential Duties and Responsibilities:



QA focal point for engineering projects in design and development processes.
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations, and standards.
Responsible for final approval of engineering documentation- reviewing and approving technical, mold and process validation documentation (IQ, OQ, PQ).
Assist and provide guidance on any out of specification result, deviation, or excursion that may occur
QA representative in equipment and process validation reviews
Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects.
Attend program meetings as required as part of extended program teams.
Provide support, when necessary, with review and approval of product development DHF documentation (DDP, PRD, TMX, design verification & validation activities, dFMEA risk documents, test methods, OOSs, protocols, reports, product design transfer)
Support other QA dept activities- second approval of batch release/graphics, routine sterility validation maintenance activities (dose audit and bioburden), calibration etc.
Responsible for final approval of engineering documentation- reviewing and approving test method validation
Competencies/Authorities

Approve equipment qualification documents (URS, pFMEA risk documents, IQ, OQ, PQ)
Approve validation protocols and reports.
Support all engineering activities.

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.