Hanen Elfarjaoui
Latina
Profilo professionale
I am a sterility assurance specialist with 7 years of experience in the pharmaceutical industry, focusing on the strategic management of sterility assurance programs. I bring strong communication, decision-making, and organizational leadership skills, with a proven ability to lead complex projects and ensure compliance with GMP and regulatory standards. Skilled in analytical risk–benefit assessment and proactive problem-solving under pressure, I am recognized for perseverance, sound judgment, and a commitment to maintaining the highest standards of product quality and patient safety.
Panoramica
10
10
anni di esperienza professionale
Esperienza lavorativa
Sterility Assurance Scientist
Haupt pharma Aenova group site
Latina
2023.12 - 2026.03
- Assisting in the development and implementation of the site's sterility assurance programme.
- Providing technical advice and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques and cleaning.
- Performing quality assurance inspections.
- Support the implementation and execution of activities for the microbial control of manufacturing, including the execution of quality risk management and on-site training.
An understanding of the manufacturing processes involved in producing biotechnological products . - Ability to build and maintain effective cross-functional working relationships with the Operations, Technical Services, Engineering, Facilities, Quality Assurance .
- Supporting the Sterility Assurance/Contamination Control programmes in Aenova Group for all manufacturing processes for Latina Site.
- Coordinating and executing training for new personnel in basic microbiology, contamination control, and aseptic techniques.
- providing on-floor contamination control support and troubleshooting.
- Identify and lead process improvements in aseptic practices and contamination control.
- Progress changes using the change control management system as required.
Adhere to the highest standards of compliance (quality and safety), implement corporate standards, and provide technical support during audits.
· Ensure compliance with site EHS policy, cGMP and other business regulations.
· Perform other tasks as identified by the Sterility Assurance Lead.
QUALITY CONTROL RAW MATERIALS ANALYST
Alfasigma S.p.A Stabilimento di Pomezia
Pomezia, RM
2023.05 - 2023.11
- Quality control, raw materials, excipients, water, packaging materials. Using the following equipment: HPLC (Agilent), UV spectrophotometer (Agilent), IR spectrophotometer (Thermo_Fisher), pH meter (Metler toledo), conductimeter(Metrohm), melting point (Antoon Paar), titolato potentiometer (Metrohm), Karl Fischer titrator (Metrohm), pyozelectric densimeter (Anton Paar), Toc, X-ray,viscometer(Anton Paar), polarimeter (Anton Paar), TLC chromatography and physicochemical analysis. Application of cGMP, GLP and SOP standards. Data entry using Lims Software.
MICROBIOLOGIST ANALYST
Alfasigma S.p.A Stabilimento di Pomezia
Pomezia, RM
2022.04 - 2023.04
- Monitoring activities in production departments. Performing validation activities (Room qualification). Identification of microorganisms using various techniques ( vitek ,PCR,The MALDI-TOF ). Application of cPerforming Microbiological analysis (Sterility Test, Microbial Charges TAMC,TYMC, LAL Test, Visible Particles Test ) on solids, liquids, stability products, packaging material .Microbiological GMP, GLP and SOP standards. Data entry using Lims software.
Ph.D. in biological sciences
Department of Chemical, Biological, Pharmaceutical and Environmental Sciences
Messina
2016.03 - 2020.09
- Isolation and phenotypic identification of fungi using classical microbiology( light microscope observation, seeding on culture media such as Sabouraud Dextrose Agar, Chromagar, ID 32C and germtube test). Species identification was confirmed by molecular methods (PCR, Real time PCR,Restriction Fragment Length Polymorphic).MLST analysis as a typing system for Candida species and data analysis by bioinformatic methods (FinchTV 1.4,MEGA10, eBURST and PubMLST)
Voluntary internship
IRCCS "Bonino-Pulejo" Neurolesis Center
Messina
2018.09 - 2019.11
- In order to study some neurodegenerative diseases like Alzheimer's and multiple sclerosis, I have worked with different molecular genetic techniques such as Southern Blotting,Northern Blotting,Western Blotting and NGS technique (Illumina sequencing).
Istruzione
Master's Degree Program - Medical Biotechnology
Department of Biomedical, Dental and Morphological and Functional Imaging Sciences
Messina2024-12
Ph.D. - Biological science
Faculty of Science Sfax\Department of Chemical
Messina2020-12
Master's degree - biotechnology science
Faculty of Science of Sfax\University of Sfax
Sfax2016-10
Bachelor of Science - Biotechnology
Faculty of Science of Sfax\University of Sfax
Sfax2014-06
Competenze
- Self-motivation
- Leadership
- Microsoft Office
- Decision Making
- Creativity
- Microsoft Excel
- Computer Skills
- Ability to Multitask
- Communication Skills
- Teamwork
- Ability to Work Under Pressure
- Adaptability
- Problem Solving
- Information Technology
- Ability to Work in a Team
- Software Lims
- Empower 3
Languages
Arabic/French
Italian
English
Spanish
Hobby e interessi
Travel , Music , Art , Technology
AUTORIZZAZIONE
I authorize the processing of the personal data contained in my curriculum vitae according to art. 13 D. Lgs. 196/2003 and art. 13 of EU Regulation 2016/679 on the protection of individuals with regard to the processing of personal data. Rome, 27/11/2024 Elfarjaoui hanen
Cronologia
Sterility Assurance Scientist
Haupt pharma Aenova group site
2023.12 - 2026.03
QUALITY CONTROL RAW MATERIALS ANALYST
Alfasigma S.p.A Stabilimento di Pomezia
2023.05 - 2023.11
MICROBIOLOGIST ANALYST
Alfasigma S.p.A Stabilimento di Pomezia
2022.04 - 2023.04
Voluntary internship
IRCCS "Bonino-Pulejo" Neurolesis Center
2018.09 - 2019.11
Ph.D. in biological sciences
Department of Chemical, Biological, Pharmaceutical and Environmental Sciences
2016.03 - 2020.09
Ph.D. - Biological science
Faculty of Science Sfax\Department of Chemical
Master's degree - biotechnology science
Faculty of Science of Sfax\University of Sfax
Bachelor of Science - Biotechnology
Faculty of Science of Sfax\University of Sfax
Master's Degree Program - Medical Biotechnology
Department of Biomedical, Dental and Morphological and Functional Imaging Sciences