Clinical Quality Assurance (QA) Specialist רמת גן
לבדיקת התאמה צור קשר כאן https://tinyurl.com/MatchJoblyNow
A Biopharmaceutical company is seeking a
Clinical Quality Assurance (QA) Specialist
to support QA-related activities across clinical trials.
The position will support the effective operation of the Clinical Quality Management System (cQMS) and provide QA oversight in accordance with ICH-GCP and applicable regulatory requirements.
Key Responsibilities:
Support the maintenance and continuous improvement of the Clinical Quality Management System (cQMS) in compliance with ICH-GCP, FDA, EMA, and applicable local regulations
Assist in the development, review, and maintenance of SOPs, work instructions, and templates related to clinical trial conduct
Support the development and execution of Study Clinical Audit Plans
Support CRO and other clinical service provider qualification and re-qualification activities
Manage Corrective and Preventive Action (CAPA) plans, ensuring timely resolution, effectiveness verification, and continuous improvement across clinical programs
Provide QA oversight for CROs and clinical service providers throughout the study lifecycle
Support inspection readiness activities and regulatory inspections, including preparation of documentation and
follow-up actions
On site - Full Time
Requirements:
Bachelor’s degree or higher in Life Sciences, Pharmacy, Nursing, or a related field
At least 1 year of hands-on experience in Clinical Quality Assurance
Alternatively (for experienced Clinical Operations professionals):
3-4 years of experience as a CRA or CTM, within a pharma or CRO environment
Demonstrated exposure to QA-related activities (e.g., audit support, CAPA management, inspection readiness, quality systems)
Clear understanding of the distinction between Clinical Operations and Clinical Quality Assurance
Strong motivation to transition into Clinical QA as a long-term career path
* משרה מס׳ #869297 מיועדת לגברים ונשים כאחד
A Biopharmaceutical company is seeking a
Clinical Quality Assurance (QA) Specialist
to support QA-related activities across clinical trials.
The position will support the effective operation of the Clinical Quality Management System (cQMS) and provide QA oversight in accordance with ICH-GCP and applicable regulatory requirements.
Key Responsibilities:
Support the maintenance and continuous improvement of the Clinical Quality Management System (cQMS) in compliance with ICH-GCP, FDA, EMA, and applicable local regulations
Assist in the development, review, and maintenance of SOPs, work instructions, and templates related to clinical trial conduct
Support the development and execution of Study Clinical Audit Plans
Support CRO and other clinical service provider qualification and re-qualification activities
Manage Corrective and Preventive Action (CAPA) plans, ensuring timely resolution, effectiveness verification, and continuous improvement across clinical programs
Provide QA oversight for CROs and clinical service providers throughout the study lifecycle
Support inspection readiness activities and regulatory inspections, including preparation of documentation and
follow-up actions
On site - Full Time
Requirements:
Bachelor’s degree or higher in Life Sciences, Pharmacy, Nursing, or a related field
At least 1 year of hands-on experience in Clinical Quality Assurance
Alternatively (for experienced Clinical Operations professionals):
3-4 years of experience as a CRA or CTM, within a pharma or CRO environment
Demonstrated exposure to QA-related activities (e.g., audit support, CAPA management, inspection readiness, quality systems)
Clear understanding of the distinction between Clinical Operations and Clinical Quality Assurance
Strong motivation to transition into Clinical QA as a long-term career path
* משרה מס׳ #869297 מיועדת לגברים ונשים כאחד