Linda Kasbaoui - Zemmit

Ensure compliance of components, consumables and products (semi-finished, finished).
Animate the quality management system in Lonay’s production site in agreement with the Head of Compliance.
Ensure the quality management system implementation in compliance with the quality assurance team and in compliance with the Good Manufacturing Practices.
With the QC/QA referant’s team, the referant is in charge of quality control in-process and in charge of the monitoring of the different production step.
Represente and in charge of application of quality assurance systems and good manufacturing practices throughout the production site.

Quality assurance:
• Participate in the implementation of quality assurance policy in compliance with the Quality Mangement System
• Raise awareness, train and lead the staff around the Quality Management System and its evolution
• Provide training on good manufacturing practices and SMQ Staff
• Participate in the monitoring and the closure of deviations,
• Ensure the conception of metrics, and periodic review
• Participate in monitoring and in the realization of the corrective and preventive actions
• Participate in the process formalization and process improvement, in qualification process.
• Write of main SOPs
• Manage of documentation & records
• Participate, prepare and realize Audit and Inspection

Quality control:
• Organize and ensure the products controls implementation and the monitoring during and after process
• Ensure the control methods respect, the hygiene & cleaning respect, the Day to Day quality support
• Check, review and verify the manufacturing and packaging batch records
• Ensure the flow of products and is in charge of the external and internal analysis, classify the information necessary for the release of products
• Facilitate the procedures compliance, the identification and traceability of products during all the process
• Participate in the analysis’s result of environmental monitoring
• Participate in continuous improvement of manufacturing and controls processes
• Management of the team.

Quality management representative in charge of computer system implementation and quality processes implementation, this includes realize service support including Service Desk for all the Lilly Site, on Deviation process, Change process, Complaints process, Audit process and CAPA process.

Coordination of Projects:
• Define the project requirement (time and resources), and sign the ressources contract.
• Establish the planning of the project, identify the problem and find solutions.
• Define and ensure the metrics.

Validation / management system and implementation of new processes (or release):
• Check that the site’s requirements are covered, review changes related to the project.
• Validate the Trackwise system (writing / reading documents for validation, test execution ...), CSQ
• Check that existing system remains in a validate state.
• Sets rules for system access, review SOP.

Process Management skills:
• Continuous improvement of processes;
• Write / review procedural documents (procedures, operating document, forms ...)
• Initiate and investigate on quality gap, implementation corrective and preventive actions

Customers support (process, system):
• Ensure support to users (daily use, data extraction, compliance process).
• Animate Key Users network, train the Key Users, the Trainers, & End Users, organize the schedule training, design / review training support.

Participation in projects (OOS, stability, setting lots of destruction, sterility assurance process)
• Participate in projects by providing expertise of the system Trackwise.
• Give expert advice on GMP document as quality business representative.
• Propose and implemente solutions.

Communication:
• Prepare and forward to people communication related Trackwise system.
• Prepare, coordinate project meeting, communicate problems/comments/proposals for improvement to the Global team.

Aim
Optimize, harmonize the training on the filling area and contribute to the operational support activities.
Production had increase during few year, but Quality no. Training were not formalized like it was required, ITP were not created per job, and nothing proved that production employee are correctly trained.

Operational support Engineer in charge of operational activities monitoring, this includes realize deviation monitoring and investigation, Corrective action and Preventive Action monitoring, training monitoring, equipment monitoring, document modification. Realize interface between Quality and Production.

Technical activities:
Ensure and realize Qualification equipment tests, create report associated Qualification process (Initial Qualification, Operational Qualification, Performance Qualification)
Ensure and realize the training monitoring of all production area, create ITP for each job in the area, ensure the training of the different activity, certify operational person to their job, ensure continuous improvement on the training, add the movie to the training job.
Create and review the GMP document and the training support.
Prepare and present answer to auditor, compilate and prepare files for inspection, audit tracking monitoring

Results :
-ITP for all the jobs created, production employee trained in compliance with ITP, creation of a training schedule, metrics weekly done
-Training harmonization between 2 staff
-Training missing for cleanroom area created
-Qualification equipment : scales, freezers, particles counters, formulation area

Aim:
Developed a technical process analysis for quantify and detect rhodamin and sudan in spicy and food product.
OMS and AFFSA had alert food companies of the critical products like curry or other spicy which are contaminated by rhodamin and sudan. These two product are carcinogenics for human.

Activities :
-Manage Crisis alert (OMS, AFFSA) : Deviations, Correctives actions, batchs release, complaints treatment, supplier/vendor research.
-Develop Analytical process validation
- Prepare audit iso 9001: manufacturing/laboratory
- Develop a Hazard Analysis Critical Control Point chart (process, logistic, manufacturing)

Results :
-Analytical process developed by HPLC method for quantify rhodamin
-New supplier have been found and started their agreement