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.
- مجال الشركة:
- الاستشارات الهندسية العامة
- الدور الوظيفي:
-
الإدارة
