Barak Aviram Email & Phone Number

Tel Aviv-Yafo, Il

Tel Aviv-Yafo, Il

Israel

Experience:• Actively performed and guided all QA validation core tasks regarding qualification of processes, equipment, and utilities.• Managed validation oversight ensuring strict compliance with regulatory guidelines.• Conducted change control records with a focus on adhering to quality and regulatory standards.• Oversaw aseptic processing simulation and environmental monitoring (Annex 1), ensuring product quality, safety and compliance. • Authored and approved risk assessments and validation reports demonstrating attention to detail and analytical skills. • Led internal audits and participated in regulatory inspections, ensuring continued regulatory compliance.• Trained and mentored new employees on QA validation processes, fostering a culture of quality, safety and compliance.Company: Bio-Technology General (Israel) Ltd., a subsidiary of Ferring Pharmaceuticals

Israel

Roles:• Quality referent of sterile filtration and aseptic filling manufacturing units.• Quality referent of protein recovery and protein purification manufacturing units.• Quality referent of biology and microbiology QC laboratories.Experience:• Actively involved in all quality core tasks• Managing quality oversight for manufacturing and QC units ensuring adherence to cGMP guidelines.• Established proficiency in cGMP regulatory guidelines, deviation investigations (RCA), CAPA management, and clean room gowning (ISO13485), focusing on maintaining product quality, safety and compliance.• Expertise in aseptic processing and environmental monitoring (Annex 1).• Performed internal audits and participated in regulatory inspections, ensuring continued regulatory compliance.• Reviewed and approved various documents showcasing attention to detail (SOPs, risk assessments).• Adept at reviewing and approving of BRs and eBRs.• Trained employees on quality assurance processes, promoting a culture of quality, safety and compliance.Company: Bio-Technology General (Israel) Ltd., a subsidiary of Ferring Pharmaceuticals

Israel

Experience:• As a member of an innovative R&D group, planned and executed research techniques such as engineered micro-organism cultivation and recombinant protein production and analysis.• Gained first-hand knowledge in recombinant protein purification using FPLC columns.Company: Bio-Technology General (Israel) Ltd., a subsidiary of Ferring Pharmaceuticals

Ben-Gurion International Airport, Tel Aviv

Experience:• Provided security service mainly in English while working as part of a team at Ben-Gurion International Airport.• This position required passenger characterization based on body language, speech, appearance, and more.

Israel

Experience: • Staff Sergeant in Givati Brigade of IDF infantry commanding over 10-20 soldiers.• Worked among high-ranked commanders while participating in soldiers' training and guidance.• Accomplished missions under stressful situations, and dynamic schedules, while demonstrating responsibility, teamwork, and leadership.