Stability Lead- Quality Control Department

Kamada is hiring a Stability Lead for the Quality Control Department

This is an excellent opportunity to take on a key professional role, leading the Stability function, managing stability studies, and collaborating with multiple cross-functional stakeholders while ensuring compliance with quality standards and regulatory requirements.

Full-time position based at Kamada's site in Beit Kama

Key Responsibilities:

• Develop, manage, and maintain the annual stability program.

• Oversee stability studies, stability files, and the stability archive.

• Lead Change Controls, CAPA activities, and investigations related to stability processes.

• Manage the site stability program and approve stability study files.

• Work with the LIMS system, including study approvals and infrastructure updates.

• Coordinate and manage sampling activities for stability studies.

• Review stability data and perform trend analysis.

• Prepare protocols, stability reports, Annual Product Reviews (APR), and deviation investigation reports.

• Support regulatory activities and submissions.

Requirements:

• Bachelor's degree in a scientific discipline, Chemical Engineering, Biotechnology Engineering, Materials Engineering, or a related field – required. Master's degree – an advantage.

• High level of English proficiency (written, verbal, and reading comprehension) – required.

• Familiarity with regulatory environments and quality processes within the pharmaceutical industry – required.

• Experience in data review and analysis, as well as writing protocols and technical reports – required.

• Proficiency in Microsoft Office applications, with strong skills in Excel and Word.

• Ability to work independently while effectively collaborating with multiple stakeholders.

Significant Advantages:

• Experience working with LIMS systems.

• Experience in Stability or Quality Control within the pharmaceutical industry.

• Experience in trend analysis, statistical evaluation, and deviation investigation writing.