Auditor - QC laboratory JB-24

At Protalix, our focus is to develop, produce and commercialize potentially better therapies for a variety of illnesses through cutting-edge research and development and our proprietary plant cell-based protein expression platform. If you wish to be a part of our success and join a dynamic and professional team that allows personal and professional growth, we are looking for you.

We’re looking for an Auditor in the QC Laboratory.

Responsibilities

As a QC Auditor, you will play a crucial role in ensuring the quality and integrity of our laboratory operations. Your responsibilities will include:

• Auditing Laboratory Activities: Conduct regular audits of laboratory activities to ensure adherence to established Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP) guidelines, and other relevant regulatory requirements
• Data Integrity: Verify the accuracy, completeness, and consistency of laboratory data.Ensure compliance with data integrity principles throughout the data lifecycle (collection, processing, storage)
• Documentation Review: Critically review laboratory documentation, including test records, COAs (Certificates of Analysis), and logbooks, to identify any deviations or deficiencies
• SOP and Protocol Management: Participate in the development, review, and update of SOPs, worksheets, and other quality control documentation
• Method Validation and Qualification: Assist in the validation and qualification of analytical methods used in the QC laboratory
• Report Review and Approval: Review and approve test reports and COAs to ensure accuracy and completeness before release
• Specification Management: Contribute to the development and maintenance of specifications for raw materials, intermediates, and finished products
• Pharmacopeia: Working with pharmacopeia for testing of Raw material-(e.g., USP, Ph.Eur., JP)
• Teamwork and Collaboration: Work effectively within the QC team and collaborate with other departments to maintain high-quality standards

Requirements

• B.SC/M.SC
• Experience: Proven experience (1-3 years) working in a QC laboratory environment, preferably in the pharmaceutical or biotechnology industry
• GMP Knowledge: A strong understanding of GMP principles and their application in a laboratory setting
• Data Integrity: Familiarity with data integrity concepts and best practices (ALCOA principles)
• Auditing Skills: Knowledge of auditing techniques and principles
• Communication: Strong written and verbal communication skills in both English and Hebrew
• Computer Skills: Proficient in using Microsoft Office Suite (Word, Excel) and experience with laboratory information management systems (LIMS)
• Teamwork: Ability to work effectively in a team environment and collaborate with colleagues