Description
Quality Systems Group is responsible for the documentation center, quality of raw materials and suppliers, implementation of procedures and regulatory guidelines, writing policy documents, and annual quality summaries.
Job Summary:
Scientific writing in English and Hebrew
Monitoring quality objectives
Supporting regulatory and customer audits
Main Responsibilities and Tasks:
Scientific writing of organizational quality documents, policy documents, and annual quality summaries of BTG products
Managing and conducting risk assessments and writing appropriate documents
Supporting the writing of investigation summaries and deviations
Reviewing guidelines from regulatory bodies relevant to the pharmaceutical industry and implementing their requirements in the organization
Preparing quality agreements with service providers, suppliers, and subcontractors
Writing an annual quality objectives plan, monitoring its implementation, and writing a summary
Participating in preparations for regulatory and customer audits, supporting their leadership, writing responses to findings, and tracking corrective actions
Requirements
Job Requirements:
Education: Master's degree with industry experience / Biology / Biotechnology
Certifications: Scientific writing, proficiency in OFFICE
Previous knowledge and experience: Scientific writing in English and Hebrew, experience in quality assurance in a pharmaceutical company
English: Very high leve