Website Sheba Tel HaShomer City of Health
This Jobsfunter Listing is about Sheba Tel HaShomer City of Health in Ramat Gan, Tel Aviv, Israel 2022
About the job
The Advanced Biotherapy Center (ABC) at Sheba Medical Center is a new, state-of-the art laboratory for developing and manufacturing new cell and gene therapies for patients with serious diseases. We are looking for a highly motivated individual with previous quality assurance (QA) experience from clinical research laboratory, biotech, or pharm industry to serve as the laboratory quality assurance specialist. Familiarity with cGMP for cleanrooms and Advanced Therapy Medicinal Products is highly recommended. The Quality Assurance Specialist works with internal Sheba groups and external biotech and pharma clients to develop and maintain quality programs for the cleanroom facility and for novel cell and gene therapies.
The job holder will report to the Laboratory Director, Dr. Jonathan Esensten.
Essential Duties And Responsibilities:
- Designs and implements quality systems including document management, supplier qualification, training, change control, deviation investigation, gowning, cleaning, CAPA, and other processes per established procedures.
- Participates in the development and revision of standard operating procedures and guidelines.
- Performs internal audits.
- Ensures readiness for inspections by audits from external regulators, funders, and collaborators.
- Applies risk management principles to decision making and operational priorities. Writes formal risk assessments.
- Additional tasks as assigned to ensure quality in cell therapy development and manufacturing activities
· BSc/MSc degree in biological sciences or relevant experience in pharma or medical device companies
· At least 2 years of experience in quality assurance in a related field
· Working knowledge of GMP, FDA and EMA regulatory requirements applicable to ATMP and HCT/P
· Advanced knowledge of Microsoft Office applications
· Meticulous attention to details and accuracy
· Organized and responsible
· Teamwork skills
· Excellent writing and oral communication skills in Hebrew and English
Company: Sheba Tel HaShomer City of Health
Vacancy Type: Full-time
Job Location: Ramat Gan, Tel Aviv, Israel
Application Deadline: N/A