Executive manager
Berwaz for industrial consultation
Total years of experience :33 years, 0 Months
Consultation of pharmaceutical industry relating to GMP
To administratively and technically manage all activities regarding GMP consultation, measuring device calibration, and system qualifications
complete management and technical role of GMP consultation, measuring Devices calibration and system qualifications and validation
Head of QA functions, with the following responsibilities:
· Management of Quality Assurance Department functions as administrative and technical wise
· Management of Documentation and training activities
· Management of auditing activity for the company.
· Coordinator and management of auditing activity for the company suppliers.
· Coordinator and member of certification team for ISO9001:2000 and ISO14001:1996.
· Coordinator and member of certification team for EU-GMP in Germany, Irish, Canadian and Swedish.
· Managing and performing validation and qualification activity for facility, analytical instruments, support utilities and production equipment as IQ, OQ, and PQ.
· Member of validation team for analytical instruments, services and production equipment.
· Establishing of Quality Manual, Documentation system, and validation protocols according to ISO-GMP regulations.
· Inspection of Factory building to be according to Food & Drug Administrative regulations (FDA), MCA regulations, and international standards such as GMP and GLP.
· Approving of Drug Formula to be stated, tested, and processed according to Pharmaceutical Pharmacopoeias and GMP.
· Approving of Drug master file to be according to GMP/GLP regulations and internal regulations.
· Assuring of raw material and product Quality through checking of analytical methods and results on a pre-defined schedule.
· Defining in cooperation with the related departments and approving of all company documents restricting these documents to company document flow.
· Responsibility of running annual product review according to latest requirement of cGMP.
· Responsibility of running investigations of product complaints and feeback reporting with corrective actions.
· Responsibility of approving suppliers of API, In-active materials, and Packaging materials through either auditing or Questionnaire or both and base on latest requirements of cGMP
Quality Assurance department, Documentation manager with the following responsibilities:
· Management of Quality Assurance and Quality Control Departments as a deputy of QA/QC manager
· Inspection of Factory building to be according to Food & Drug Administrative regulations (FDA).
· Approving of Drug Formula to be stated, tested, and processed according to Pharmaceutical Pharmacopoeias and Good manufacturing practice Regulations.
· Approving of Drug master file and drug registration file to be according to GMP/GLP regulations and internal regulations.
· Assuring of raw material and product Quality through checking of analytical methods and results on a pre-defined schedule.
· Defining in cooperation with the related departments and approving of all company documents restricting these documents to company document flow set by the documentation department.
· Member of Raw Material (Includes packaging material) and Product specification committee.
· Responsibility of running validation and Qualification team to ensure proper work of all analytical instruments and production instruments.
· Head of auditing team for the company on a yearly basis.
Quality Assurance department, researcher in QC/QA department with the following responsibility:
· Insuring of applying Factory building according to Food & Drug Administrative regulations (FDA).
· Assuring of raw material and product Quality through checking of analytical methods and results on a pre-defined schedule.
· Defining in cooperation with the related departments and approving of all company documents restricting these documents to company document flow set by the documentation department.
· Member of validation team as a group with MRC company - UK
· Production engineer with Complete responsibility of Soap Lab and factory
· ISO 9000 team member in soap factory
· Production engineer in the united sulphonation company
· Researcher in ICA for sulphonation technology improvement under the supervision of Dr. Ahmad Kassim - Planning & Technical director.
M.E. in chemical engineering (Rank 3/8) Reactor Modeling & Design (Sulphonation reactor modeling, design & manufacturing)
B.E. in chemical engineering (Rank 5/24) Plant Design (Cyclohexane plant design)
Scientifical Approach Certification of French Language through "Certificate and Breuvais" Exams Rank of 20/70 with a grade of 92%