Suleiman Odeh Email & Phone Number

Amman- Jordan

email Suleiman.aldajeh@gmail.com

R&D Manager and project manager, (pharmaceutical services, CRO, and Savvy pharma) Triumpharma, Jordan.- Follow up QMS in both factory and CRO (GLP, GMP and GCP). -Prepare technical files (CTD format) starting from literature survey, pre-formulation, formulation, Method Development, Method validation, Stability study and final report for solid dosage form and semisolid (DOING SPECIAL FORMULA COMBINATION) and finally scale up, with best way for bioequivalence-Project manager for product development for clients.-Starting in dev. Oncology products.-General manager delegated many tasks in and outside company. -Tech. transfer for products outside Jordan with manufacturing; process validation; method analytical validation and cleaning validation and 3batches for stability and one batch for bioequivalence study.-Head of team prepared for USFDA auditing for the CRO and we got the USFDA Approved.-Member of team prepared for AFFSAP auditing for the CRO and we got the AFFSAP Approved.-Development for MOA and Method validation for outside companies in and out of Jordan.-head of independent lab. For outside companies. - Head of GMP team for GMP certificate from JFDA and we got the GMP certificate for the factory.-Consultations for trouble shooting for companies, External audit, production and MOA…etc.-Trouble shooting for bioequivalence studies ( which failed in bioequivalence).-One of the team of GCP, GLP for the CRO.-follow up the validation department to improving as per the latest guideline. -established pharmaceutical Factory from starting QS, HVAC, QC Lab with relating instruments, Production area, Production Machine from offering till installation, finally we already got the JMP certificate.

R&D Manager and project manager, (pharmaceutical services, CRO, and Savvy pharma) Triumpharma, Jordan.- Follow up QMS in both factory and CRO (GLP, GMP and GCP). -Prepare technical files (CTD format) starting from literature survey, pre-formulation, formulation, Method Development, Method validation, Stability study and final report for solid dosage form and semisolid (DOING SPECIAL FORMULA COMBINATION) and finally scale up, with best way for bioequivalence-Project manager for product development for clients.-Starting in dev. Oncology products.-General manager delegated many tasks in and outside company. -Tech. transfer for products outside Jordan with manufacturing; process validation; method analytical validation and cleaning validation and 3batches for stability and one batch for bioequivalence study.-Head of team prepared for USFDA auditing for the CRO and we got the USFDA Approved.-Member of team prepared for AFFSAP auditing for the CRO and we got the AFFSAP Approved.-Development for MOA and Method validation for outside companies in and out of Jordan.-head of independent lab. For outside companies. - Head of GMP team for GMP certificate from JFDA and we got the GMP certificate for the factory.-Consultations for trouble shooting for companies, External audit, production and MOA…etc.-Trouble shooting for bioequivalence studies ( which failed in bioequivalence).-One of the team of GCP, GLP for the CRO.-follow up the validation department to improving as per the latest guideline. -established pharmaceutical Factory from starting QS, HVAC, QC Lab with relating instruments, Production area, Production Machine from offering till installation, finally we already got the JMP certificate.

Member of “Quality Assurance department, Instrumental & analytical supervisor in QA/QC Dep. (Having a QC manager duties when QC manager absent and Documentation Supervisor once absent), -GMP Team Riyadh Pharma Company, internal auditing team and external auditing for raw material and packaging materials suppliers Riyadh /KSA.-Prepared URS, FS, DQ, IQ, OQ and PQ protocols.-responsible for documents for all machines and instruments in the company-R&D with QC department, so I check the scale up with solving the problems, with finalized the process validation protocol.- Investigator for trouble shooting for failed formula for most dosage form solid, semi solid and liquid formulas.-project manager for one product have to register in Europe.-Start up and validation of new aspect, facility included QC instrumentation ( Most types of HPLC, GC, FTIR, DSC, TGA, UV, KF, Autotitrator, Dissolution…etc) -Developed method of analysis for inhaler product with full validation for MOA, and prepared IQ, OQ protocols for the instrument used.- Process validation protocol; manufacturing validation; analytical method validation and cleaning validation.-Responsible for Reference and working standards and the certified of all working standard used in company.-Responsible for stability chambers mapping and calibration.-follow up for trouble shooting in the production area with preparing of OOS report

Master Mba

Bsc, Chemistry, Master Mba (Mager Is Quality)

Ip Expert, Intellectual Property Law

Activities and Societies: 1-Review and help to have high protection patent. 2-To give the best way for pharmaceutical and other sector's.