ميريام كنعان

Responsible for leading all technical activities across Benta Pharmaceutical Industries, Medical devices & Intraocular lenses which includes Development and Pilot (D&P) Laboratory, Production and Maintenance departments:
 Lead and direct all activities concerning new product development and formulation activities, in a robust state for commercial manufacturing including technical transfers, development reports, CTD fillings, process validation, and others.
 Lead and direct all activities concerning production and packaging activities of solid, liquid and sterile forms of generic products, medical devices and intraocular lenses.
 Lead and direct all activities concerning the maintenance activities of all machinery related to the D&P and manufacturing areas (corrective, preventive and predictive) including the stock management of machinery spare parts.
 Provide significant technical depth to support troubleshooting efforts and lead high-level deviation investigations at internal and external manufacturing facilities.
 Ensure the implementation of departments planning and schedule such as process development plan, production planning and maintenance schedule planning.
 Work with all concerned departments to assure that Benta strategy is aligned with all others and vice versa.
 Approve and manage all necessary documents related to D&P, production and maintenance operations (procedures, forms, batch records …) and ensure its strict implementation.
 Support validation readiness activities across manufacturing network.
 Recruit, manage, motivate all D&P, Production and Maintenance team and review their performance after setting their key performance indicators.
 Ensure proper technical and specific training of the team according to their needs.
 Seek out competitive advantages for Benta sal (formulation, technology differentiation, packaging, innovation, ..)
 Drive timely decisions and facilitate active cross-functional technical communication and information flow between team members.

Teaching 3 courses “Pharmaceutics” and “Pharmaceutical Technology” (30 hours each) and Laboratory “Pharmaceutical Industry and Technology” for 24 students.
 Preparation of courses presentation.
 Preparation and correction of quizzes and finals.

Project Leader of the Technology Transfer from Sanofi Aventis to Benta for 17 products that will be manufactured in house.
 Development of the project plan.
 Management of the project team.
 Management of the project schedule and budget.
 Follow up of the project execution and delivery.
 Execution of the production part.

 Ensure that the products are manufactured and packaged efficiently on time with the required quality and quantity.
 Monitor the production processes.
 Assure that the aseptic preparation rooms are monitored and qualified for use and that all required tests are conducted as per current good manufacturing practices.
 Draw up the production schedule and ensure its implementation.
 Responsible of the validation processes of all products produced and the revalidation based on any change.
 Recruit, manage, motivate all production team and review their performance after setting their KPIs.
 Ensure proper technical and specific training of the production team according to their needs.
 Write, approve and manage all necessary documents related to production operations (procedures, forms, batch records, …) and ensure its strict implementation.
 Review all batch records and assure full investigation if any deviation occurred.
 Formulate the new product to be manufactured and process the pilot batches and compile module 3 of the common technical data required for the registration.
 Perform the self-inspection and the internal audits on other units as per ISO 9001:2016.
 Part of the design committee to approve the content, design and size of the packaging components.

 Assure that the formulation processes are conducted as per current good manufacturing practices.
 Review the batch records of the pilot batches.
 Write all the necessary documents (protocols and reports) related to the validation processes.
 Write the necessary documents related to the formulation department.
 Assure the proper on the job training for the operators.
 Be part of the change control committee.
 Be part of the plant auditors committee.
 Assure the full investigation and reporting of any deviation occurred.

internship in the Clinical Research Institute:
 Establish general procedures and guidelines to standardize the activity of the clinical development project manager in the dermo-cosmetic’s department.
 Assist the project manager in the planning, executing and monitoring of the project

 Establish a suprabioavailable form of acyclovir as a project for Industrial Pharmacy Labs in Bordeaux II University, in partnership with Physica Pharma Corporation.

 Pharmaceutical intervention and clinical analysis in cardiovascular and oncology cases as well as internal medicine, infectious disease, pneumonia, pediatry and reanimation.