Mohammad Afifi Email & Phone Number

Cairo, Egypt

1. Creation of URS for different activities required in the project2. Technical comparison between different suppliers for the activities required in the project3. Follow up the consultant activities for conduction of Conceptual, Basic and Detailed design 4. Review the outcomes of the conceptual, Basic and detailed design and follow up their internal approval5. Review, approve and follow up the internal approval of DQ, FAT and automation documents of different machines needed in the project 6. Responsible for budget estimation for the project and follow up for its adherence7. Creation of the time plan for the project and follow up for its adherence

Egypt

1-Responsible of achieving the required volumes of sterile products.2-Responsible of achieving the required OEE for the machines and planning to increase it.3-Manage all the resources and activities in the sterile powder filling plant.4-Participate in the Plant revamping activities to meet the quality and forecasted volumes demand.5-Participate in the tolling out activities of some SKUs to another site.6-Lead lean workshops to increase the OEE, OPE and the yield figures of the plant.7- Upgrading the filling line to increase its output by 10 % and participate in the qualification and validation of the upgrade project8-Changing the working organization to eliminate the downtime of filling line. 9-Preparation of URS for ampoule liquid filling line, vial powder filling line, autoclaves and integration for c-RABS to an existing conventional based m/c10- Participate in the planning for major projects in the sterile section11-Act as SANOFI Cairo site RABS expert as being trained on the integration of RABS technology on currently existing conventional filling m/cs at Lulebergaz site (Turkey)12- Participate in the lean design of the Sterile Powder Filling Area Layout13- Participate in the supplier comparison for the Sterile Section Projects14- Change Leader in Fit 4 Future project (SANOFI global project to increase the yield, OEE, OPE and solve the irritants by applying lean tools)15- Lead the qualification and startup of the Serialization project in the Sterile Powder Filling Area16- Prepare the Business Continuity Plan for the Sterile Section17- Estimation of the next year CAPEX and OPEX budgets

Egypt

1- Planning to increase the output of the Plant by 20 % 2-Manage the sterile Powder filling plant to work on 24/7 bases3-Develop and train new operators and supervisors to work on 24/7 bases4-GAP analysis for the quality documents to meet SANOFI guidance and standards “In sterile powder filling area”5- Participate in The HSE excellence team6-Participate in lean workshops in other department (TPM and SMED)7-Participate with the IT and QA teams to secure the electronic systems form corruption and data loss.

Egypt

1- Planning to increase the output of the ampoule area by 36 % “Over the max. sealing capacity of the area”2-Introduce the 24/7 operation concept to SANOFI Cairo Site3-Develop and train new operators and supervisors to work on 24/7 bases4-GAP analysis for the quality documents to meet SANOFI guidance and standards “In sterile ampoule area”5-Participate in ISO 14001 preparation and audit

Egypt

Vials, Eye drops and lyophilized products line. "From 18-10-2011 till 20-2-2013" " and "From 16-11-2013 till now "1- Preparation of different products forms including true solutions (of low and high viscosity) and suspensions(including gels) eye drops.2-Preparation of different products for lyophilization.3- Responsible of scaling up the batch size from Lab. Scale to production scale for vials and eye drops products.4-Responsible of terminal sterilization of LVPs.5-Follow up the lyophilizer (batch parameters operation, CIP, SIP “including their validation” and shelf mapping validation).6-Follow up the filling process of eye drops and vials.

Saudi Arabia

1-Responsile of issuing and reviewing the validation protocols of the lyophilizer and its utilities.2-Responsible of the conduction and results analysis of performance qualification.3-Responsible of the technology transfer of different lyophilized products between different sites.4-Responsible of the optimization of different lyophilization cycles to fit different sites.5-Responsible of the operation and follow up the maintenance in assistance of the engineering department.6-Responsible of issuing different BMRs for the lyophilizer including engineering runs, media fills, validation and commercial batches.7- Preparation of different products (vaccines) to be lyophilized and other true solution products.8-In process control of all the products.

Egypt

Ampoules line -GSK toll manufacturing line. "From 01-08-2010 till 17-10-2011"1- Sterile preparation, processing and filling of GSK ampoules.2-Follow up of GSK packaging line according to c-GMP guide lines.

Diploma, Total Quaility Managment, A

Activities and Societies: Planning for Top Quality Managing Quality functions Project Management Lean Six Sigma

Managment Essentials

All Essential knowledge for the manager including personality traits, giving of effective feed back and who to deal with group.

Lean Six Sigma Green Belt, Lean Six Sigma, A

Project Management

Lean Six Sigma Yellow Belt

Clinical Pharmacy Diploma, Clinical, Hospital, And Managed Care Pharmacy, Good

Bachelor Of Pharmacy - Bpharm

Bachelor Of Pharmacy (B.Pharm.), Pharmaceutical Sciences, Very Good

Education record