Associate Technical Director
Benta Pharma Industries
مجموع سنوات الخبرة :20 years, 4 أشهر
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.
Master 1 and Master 2 with Merit scholarship from the « Agence Universitaire de la Francophonie » for abroad master
Merit scholarship from the « Agence Universitaire de la Francophonie»
Certificate in production and firm management
Rated 2nd over 45. Thesis: Parenteral Nutrition’s Complications - Refeeding Syndrome; Very honorable with jury congratulations. During the years in faculty, completion of 3 units value in homeopathy, dermo-pharmacy and OTC’s product