Reab Jaralla

Process Engineering Consultant

Aseptic production | Cleaning | GMP | Quality

Summary

Reab, an MSc in Pharmacy graduate from 2020, brings a fresh perspective and dynamic energy to the pharmaceutical industry. Despite being a recent entrant, Reab has swiftly accumulated a wealth of experiences across various facets of the sector. His professional journey unfolds as follows:

Six months dedicated to ensuring precise medication supply and providing valuable medical advice as a pharmacist
One year as a manufacturing pharmacist, specializing in aseptic production of individual-dosed treatments within clean rooms. This role involved both manual processes and automated methods, including the use of a pharmaceutical robot
Over two years in a management role overseeing <20 employees, with responsibilities spanning clean room qualification, maintenance, and overall team leadership
Currently operating as a Process Transfer Specialist within CDMO Although being a recent graduate, Reab brings a profound understanding of pharmaceutical processes and a commitment to excellence, making him an asset to any team aiming for top-tier quality and efficiency.

Special Competences

Reab’s contributions span:

Facilitate the seamless transfer of processes from the development department to production
Deliver training to production personnel on new processes, ensuring a smooth transition
Conduct comprehensive reporting and perform risk assessments, addressing both process and environmental health and safety (EHS) concerns
Investigate root causes of deviations, ensuring a thorough understanding and resolution
Provide crucial production support to optimize workflow efficiency
Execute process transfers between different sites, ensuring consistency and compliance
Represent the production department during customer audits and visits, showcasing operational excellence
Oversee the qualification and maintenance of clean rooms
Manage the setup and operation of manufacturing processes within clean room environments
Uphold clean room cleanliness and sterility, adhering to regulatory requirements
Contribute to the successful execution of aseptic manufacturing processes, including manual and automated methods
Navigate temperature mapping and qualification of various clean room production areas
Clean Room Operations: practical knowledge in clean room work. Experience includes managing manufacturing processes, ensuring compliance with cleanliness and sterility standards. Adept at aseptic manufacturing, with a focus on both manual and automated methods, and has familiarity with temperature mapping and qualification in clean room production areas. • GMP: Prepare and execute documentation fulfilling EU (EudraLex) and US (FDA) requirements to Qualification and Validation
Personal: Ambitious, Driven, Professional, Positive, Responsible, Open-minded, Proactive & solution oriented, Service minded.

Project Experience

Several Product projects, Up-stream, from FAS I to FAS III
Project member and responsible for production activities regarding synthesis and cleavage. (Write batch record, educate production personal, equipment compatibility, risk assessment (EHS, process), production lead before, during and after production for the product, review qualification document. Polypeptide, Sweden
Investigation of contamination in clean room facility
Project member (Manufacturing) Investigation of contamination in clean room facility through screening using several CFU- and particle-detecting methods over time to identify root cause for contamination. ApoEx, Sweden
Installation and maintenance of Class II Laminar Flow Bench
Project lead (Manufacturing) Procurement, risk assessment, compatibility studies, validation planning, calibration and testing. ApoEx, Sweden