Requirements:
Education: Engineering degree in Chemical, Industrial, Mechanical or a B.Sc. in Physical/Biological Sciences; or CQE certification and significant practical experience.
Experience: Three to Five years of experience with responsibilities including validation, quality engineering and supervisory level in medical devices or pharmaceutical industry.
Languages: Hebrew- speaking, reading, and writing at a mother tongue level.
English- speaking, reading, and writing fluent.
Responsibilities:
• Develop, modify, apply and maintain quality procedures, work instructions and protocols:
o Conducts investigations and leads corrective/preventive action planning and problem solving efforts.
o Ensures corrective/preventive measures meet acceptable reliability standards and that documentation is compliant with requirements.
o Conduct material, component, and equipment qualifications.
o Conduct internal audits.
o Provide input to engineering, production, and materials to ensure compliance with procedure, regulations, and standards.
o Utilizes statistical analysis and recognized quality tools (FMEA, risk analysis, hypothesis testing, and root cause analysis) to perform job duties.
o Data Integrity requirements-
Maintain the local systems
Evaluate and review CSV, electronic records relevant documents for GMP-compliance under 21 CFR Part 11 requirements.
Monitor and control the validation and revalidation activities for new and existing automated systems and software applications.
Evaluate and approve local IT-changes.
Qualification of IT-Systems, Automated systems, Production technical equipment / infrastructure:
• Lead as the QA/Compliance responsible through the different project phases.
• Evaluate and approve the qualification documentation, i.e. URS, GxP-Risk Assessment, Validation plan, IQ, OQ, PQ and Validation report.