Quality Assurance Engineer
- תל אביב
- משרה קבועה
- משרה מלאה
- Lead and support quality investigations (deviations), ensuring thorough root cause analysis and implementation of appropriate corrective and preventive actions (CAPA).
- Author and manage risk assessments related to deviations and changes, ensuring alignment with product quality and patient safety.
- Prepare and approve product disposition justifications related to deviations, ensuring adequate mitigations are in place.
- Serve as the QA representative in cross-functional project teams within manufacturing, ensuring quality requirements are met throughout project execution.
- Review and support change controls, including leading functional impact assessments and risk analyses, to ensure continued product quality and compliance.
- Maintain compliance with GMP and other applicable regulatory standards.
- Perform other assigned duties as needed.
- Bachelor/master's degree in science/technology/engineering/Industrial engineering or relevant field.
- 2-3 years of related experience preferred
- Strong understanding of GMP principles and regulatory requirements.
- Experience in quality investigations, risk management, and deviation handling within a pharmaceutical or biotech environment.
- Ability to collaborate cross-functionally and communicate effectively.
- Detail-oriented with strong documentation and analytical skills.
- Willingness to perform duties in accordance with policies and comply with industry regulations.
- Ability to write clearly and concisely in English and Hebrew
- Strong interpersonal and communication skills, with ability to work effectively in cross-functional teams
- Attention to detail and ability to manage multiple priorities in a dynamic environment
- Familiarity with regulatory guidelines (e.g., EMA, FDA, ICH) - an advantage
Mploy