Planning and Toll manufacturing manager
Rameda pharmaceutical
مجموع سنوات الخبرة :13 years, 4 أشهر
Toll manufacturing manager (toll in) manger
Responsible for planning
Complete supervisin for all production stages in all toll manufacturing plants.
- Communicate with supply chain, Regulatory affairs, Business development, portfolio,
sales and marketing for all production stages for current products and pipelines
products to guarantee of all products stock in market and all regulatory issues for
commercial.
- Responsible for production plan with all departments and toll plants.
- Issuing purchase requests (PRs) and BOM for all Biomed products.
training course (Orient Co.) (Dr.
Mohamed Fahmy)).
• 8 November 2021: MBA at RB college.
o Tablet processing (preparation, compression, blistering and packaging).
o Capsule processing (preparation, filling, blistering and packaging).
o Powder for oral suspension (filling, labeling and packaging).
•Toll
o Sterile production senior section head for Sterile Vaccine, sterile eye drops area and WFI (Water
for Injection) area as responsible of Preparation by SCADA software system, filling (IMA Filling
Machine), Labeling (Libra Labeling Machine) and packaging of Alcon eye drops products and
BFS (Blow fill and seal) of WFI ampoules on Rommelag machine.
o Integrity test for all products of cartridge fillers by using palltronic flow star integrity tester.
o CIP -SIP by means of automatic SCADA software system (closed system).
o Autoclave (Fin-aqua) for sterilization of garments, machine parts, leak test, …etc.
o Complete supervision on sterile area supervisors for Environmental monitoring during all
processing stages.
Clean in Place (CIP) and Sterilization in Place (SIP).
o Preparation of environmental conditions report from Building Management System (BMS)
including temperature, relative humidity and differential pressure for revision.
o Daily checking of production utilities such as Water for Injection (WFI) and Clean Steam for
suitability before starting manufacturing.
o Ensure completeness of documentation as per Good Documentation Practices.
o Follow up progress of activities (e.g. documentation approval) with the supportive departments.
o Perform WFI distribution loop and tanks sanitization with the utilities personnel assistance.
o Participate, and assist in resolution of quality investigations, support on troubleshooting activities,
suggest solutions and actively participate in problem solving process.
o Participate in special projects, during audits and regulatory inspections.
o Assist in parenteral operations validation and qualification activities and in manufacturing
activities in other areas within operations as required.
o Assist in on the job training for new employees.
o Support environmental monitoring program and annual requalification program.
o Maintain housekeeping within controls and aseptic environments, according to procedures and
handling of hazardous and non-hazardous waste according to EHS requirements.
o Startup of Vial& Ampoule line.
o Responsible of toll-manufacturing of cephalosporin vial line (external manufacturing in Sanofi-
Aventis Pharmaceutical (Filling& Packaging).
o Member of committee responsible for sterile area layout also selection and implementation of
HVAC, machines, tanks, distiller, Autoclave, steam generator, qualification, validation.
o Receiving production plan and follow up receiving of starting materials, preparation, filtration,
sterilization (aseptic,
o terminal), Ampoule filling, Vial filling, capping, visual inspection, labeling and packaging then
delivering goods to quarantine area.
o Implementation of documentation system.
o Qualification, calibration and validation of equipment’s, filters and processes.
o Startup of ampoule filling machine.
o Media fill for Ampoules 2ml and 5ml.
o Media fill for vials 30 ml and 100 ml.
o HVAC system validation & qualification (DOP. test, Air speed, particle count, differential
pressure).
o Autoclave validation (porous, non-porous, liquid) and calibration.
o Cleaning validation including maximum holding time for cleaning.
o Participation in process validation for all sterile products.
o Participation in determination of Sterilization maximum holding time after filtration, autoclaving
or fumigation.
o Lyophilization: validation and qualification, Preparation, loading and unloading parameters with
acceptance criteria, Lyophilization of different type of vials, troubleshooting during the process,
CIP, and SIP.
• Toll Manufacturing Manager:
o Toll-out manufacturing:
o (1) Tablet and capsule manufacturing line (solid-dosage form) (preparation, compressing, filling,
blistering, coating, packaging………..etc.) in El-Debieky Pharmaceutical Co.
o (2) Ampoule manufacturing line (sterile-dosage form) (preparation, filling, sterilization,
filtration…etc) in El-Nile & Emic united Companies for chemicals industry& Pharmaceuticals.
o (3) Veterinary oral powder line (Non sterile-dosage form) in Arab pharmaceutical Co. for Gelatin
products (Preparation, filling, packaging ….…..etc.).
o (4) Beta lactam Dry-mix antibiotics manufacturing line in Misr & Sigma Tec pharmaceutical
companies. (Amoxicillin Clavulanate & Amoxicillin tri hydrate products).
o (5) Sterile cephalosporin vial line (external manufacturing in Sanofi-Aventis Pharmaceutical
(Filling& Packaging).
o Toll-in manufacturing:
o (1) Manufacturing of sterile vet. Injection vials products for El-Debieky Pharmaceutical Co.
o (2) Manufacturing of Tablet products for Hope-medical Pharmaceutical Co .
o (3) Manufacturing of suppository (semi-solid) products for Adwia Pharmaceutical Co.
o Planning of all Toll manufacturing products (Toll-in& out):
o (1) Review with Marketing &Sales departments (annual, half-annual&3 months) forecast.
o (2) Review with Purchasing department all missing materials (raw materials&1ry and 2ry
Packaging materials) to provide safety stock of manufacturing .
o (3)Preparation of Toll-in& Toll-out monthly &weekly plan as priority of sales& marketing
demand.
o Follow up production cycle to achieve production plan.
o Responsible for completing financial issues related to manufacturing.
Principles of Tableting training course (Pharmex) (Dr. Abdel Hameed El
Shami).
• 31 May to 1
Mini MBA Course (Knowledge training).
• 16
: start
. in
Analytical chemistry) (Excellent),
. in special chemistry
