Oluranti Sonaike Email & Phone Number

Pomezia

• Lead the team of Quality Specialist focused on Complaint investigation, NCR investigation, Change management, SOP review, and production floor quality support• Develop and manage work assignments, analyze and trend Quality Performance data• Use of problem-solving methods to improve processes and eliminate Quality issues• Support site to ensure the Quality System adheres to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other regulatory standards• Establish individual and team objectives to attain key metric performance and ensure alignment to the overall Quality Strategy• Lead the team’s talent development process and knowledge development

Pomezia, Lazio, Italia

Provide quality assurance support to Manufacturing Operations by resolving quality-related issues, improving product quality by investigating customer complaints. Utilize the Correction and Preventive Action system to pursue continuous improvement of the Quality System and Cantel Medical products. Prepare and maintain accurate audit registrations to support audit findings. Manage and review Quality System documentation ensuring document control application and effectiveness.• Project Management: EMEA Complaint Handling Project for the standardization of the Complaint Handling Process across EMEA, through the implementation of the Global Quality System Requirements.• Ensure product complaints are promptly investigated and, where needed, adequate corrective/preventive actions are accordingly raised and implemented.• Manage NC’s process for Chemistry products and EM machines (including support to the management of raw materials/components issues raised in Incoming and Production areas).• Support CAPA’s process and follow-up on corrective actions to ensure that they are implemented on time and are effective.• Participation on-demand in preparation of PFMEAs.• Evaluate opportunities for improvements to the operation of the QA department.• Support the periodic review of department internal control procedures.• Where necessary, gather and trend COMPLAINTS quality data for periodic review and Quality Management Reviews.• Support the QA Supervisor for internal and external audits activities.• Assist the QA Supervisor in developing the corrective action plans for any findings resulting from internal and external audits.• Ensure that personal training records are maintained in conjunction with the HR department

Rieti, Italia

• Responsible for deviation and product impact assessment with respect to validated process protocols, risk assessments (pFMEA, technical documents), regulatory, compliance and internal SOP requirements;• Determination and leveling of the deviations (events) based on a criticality/occurrence mode of analysis• Ensure all containment and corrective actions, technical investigations and CAPA meet their deadlines;• Provide internal training and support to CAPA Owners with the execution of the various QMS phases and Trackwise 8 System Management;• Review investigation, technical reports and CAPA records with associated documents before closure;• Perform Internal Investigations and Supplier request for CAPA;• Attend periodic meetings for KPI departmental review and CAPA related problem-solving activities;• Responsible for the business spend management (COUPA) of the QA department and for the purchase order request of samples test characterization, training and general services;• Quality Project Management for Continuous Improvement;• Support to Audit and Corporate/FDA/AIFA inspections;• Product Quality Report (PQR) execution;• Quality Ambassador responsible for the communication and spreading of global and local initiatives.

Santa Rufina, Rieti

Perform initial investigation and CAPA determination;•Ensure all containment and corrective actions, technical investigations and CAPA meet their deadlines;•Support CAPA Owners with the execution of the various CAPA steps and Trackwise 8 System Management;•Review investigation reports and CAPA records with associated documents before closure;•Perform product Impact Assessment with reference to Risk Assessments, Technical Documents, pFMEA and Licence•Attend periodic meetings for Key Performance Index (KPI) departmental review and CAPA related problem-solving activities•Product Quality Report (PQR) execution•Blue Belt Project Management for Continuous Improvement ”Disallineamento procedurale del confezionamento dell’Albumina bulk Flex”•Quality Project Management "Risk Assessment e introduzione del Filtro Guardia sugli step di Filtrazione"•Auditing/On the floor activities in Vienna Plant (Industriestraße/Benatzkygasse) relating ICAR resolution•Presentation of Deviation and CAPA operational mechanism during Shire Global Corporate visit •Support to Audit and Corporate/FDA/AIFA inspections

Santa Rufina, Rieti

Deviation and CAPA Management with focus on root cause identification:• Investigation with focus on Manufacturing and Technical issues with Six Sigma (Yellow Belt) tool and DMAIC approach• Drafting Investigation Reports and Managing CAPA Records on TW8 GEMS• Review investigation reports and CAPA records • Implementing Corrective - Preventive actions and perform Effectiveness Checks• Monitoring KPI departmental indicators• Lead Interdepartmental Investigation team for root cause assessment• Participate periodic meetings for Investigation status follow-up• Perform re-training and SOP review

Santa Rufina, Lazio, Italia

Deviation and CAPA Quality Management System:• Perform CAPA determination• Ensure all activities, containment, corrective action, investigation and CAPA meet their deadlines• Support CAPA Owners with the execution of the various CAPA steps and Trackwise 8 management• Review CAPA records with associated documents before closure• Product Impact Assessment of the Quality Assurance’s responsibility• pFMEA and Risk Evaluation of Albumin Bulk final filtration and packaging• Perform Investigation and ICAR report

Rieti Area, Italy

• Perform Batch Record Review on-the-floor and post-production• Inspect production activities and cleaning for GMP and SOP compliance.• Execute environmental monitoring following bioburden OOL• Project Management: "Integration of Production Planning and Quality Operation Batch Record verification" for alignment between BR and the LIMS BRR verification• Verify the implementation of corrective and preventive actions• Pre-scanning of production during customers and Regulatory Authorities Audit (MOH, ISO, AIFA, FDA)• Interdepartmental cooperation and communication (Production, Engineering, Training Department)• Notify Deviations via TrackWise8• Support investigative activities following deviations / CAPA / of improvement activities

Rieti Area, Italy

• On-the-floor surveillance programme to guarantee GMP and SOPs compliance• Identification of room for improvement and implementation of preventive/corrective actions to increase GMP compliance at Production site• Batch Record preparation, registration and release for Production site utilization• Batch Record review for GDP, error and compliance before final delivery to Batch Release Division• Perform and support investigation activities following Deviations/ CAPA/ improvement activities

Rieti Area, Italy

• On-the-floor surveillance programme to guarantee cGMP compliance.• Identification of room for improvement and implementation of preventive/corrective actions to increase cGMP compliance at Production site.• Batch Record preparation, registration and release for Production site utilization.• Batch Record review for GDP, error and compliance before final delivery to Batch Release Division.• Perform and support investigation activities following Deviations/ CAPA/ improvement activities.

Rome Area, Italy

Customer serviceMerchandising and monitoring floor stock

Siena Area, Italy

Microbiology and Virology LaboratoryAzienda Ospedaliera Universitaria Senese (Siena University/Hospital)Thesis Title: "Integration of host and virus genetics to predict response to anti-HCV therapy". Sequencing and genotypic determination of Hepatitis C virus (HCV) drug resistance . Molecular diagnostic of HIV and HCV infection and quality analysis . Samples handling in laminar flow cabinet . Qiagen EZ1 advanced XL and EZ1 DSP nucleic acid automated extraction . Improm-II Reverse Transcription Reaction . GoTaq® Hot Start Hemi/nested PCR . Gel electrophoresis, separation and analysis of nucleic acid . Applied Biosystem 3130 XL Genetic Analyzer. Handling pathogenic agents in Laboratory with biosafety security level 3 (BL3). Mammalian cell culture. GLP

Rome Area, Italy

Cash management, store opening and closing, customer service andcomplaint handling, stock receiving and organizing, cleaning and maintenance of sales floor and stock room

Rome Area, Italy

Ecotoxicology and Microbiology LaboratoryThesis title: "Long-term warming of a subarctic heath decreases soil bacterial community growth but has no effects on its temperature adaptation".Microbial culture and Hormesis studies.Gram coloration, Antibiogram.Quantitative analysis and growth curves.

Master'S Degree, Medical And Pharmaceutical Biotechnolgies, 110/110 Cum Laude

Acquired knowledge of the morphology and functions of the human organism, clinic and pathological mechanism of the most important human.

Bachelor'S Degree, Biotechnology

Biotechnology

High School, Math And Science Academy, 100/100