QA Referent

תיאור תפקיד

Phibro seeking a QA Operation referent, for our leading manufacturing site at Beit Shemesh. Reporting to QA team leader.

Essential Roles and Responsibilities:

•  Ensure GMP compliance of Phibro to support manufacturing and commercial activities.
 • Prepare, review, and approve documents related to the interfacing department (including SOPs, validation protocols and reports etc.)
•  Provide on-the-floor or with camera aid of QA oversight for manufacturing activities, as needed.
• Review, assess and approval (if qualified) of investigations, risk assessments, change controls, deviations, and CAPA.
 • Ensure that the manufacturing operators work according to regulatory guidelines and relevant procedures.
• Constant readiness for internal and external inspections. 
 •Review and approve of manufacturing batch records.
• Support on site and virtual audit activities, to ensure ongoing compliance. 

Requirements:

•    Bachelor's degree in biological / Biotechnology field 
•    2-3 years of experience in the pharmaceutical industry- a must
•    Direct knowledge and experience in process and/or Quality of manufacturing within a pharmaceutical GMP environment is desired.
•    Additional experience in other areas of quality – Advantage 

3. Specialized Knowledge or Skills 
• Proficient in quality principles in a manufacturing facility.
 •Must be able to work under pressure and meet deadlines, while maintaining a positive attitude.
• Knowledge of Quality Assurance requirements in local and EMA regions is required.
• Proficient in root cause analysis and risk assessment methodologies
 •Have good communication skills and able to work in collaboration.
• Effective time management; deliver results on time.
 •Excellent computer proficiency (MS Office – Word, Excel, Power Point and Outlook).
• Has the ability to read, write and communicate in Hebrew and English.