1. Full Name ……………...….…… : Ehab Mohamed Abd Elgawad Manse
Marital Status ……….………… : Single
Date Of Birth ………...………... : 29-09-1982
Place Of Birth ……….………… : Cairo, Egypt
Military Status ………………… : Exempted
Nationality …………...…….….. : Egyptian
Home Telephone ……..……….. : +2 (02) 22741774
Mobile Number ……………….. : +2 0122 2736441
E-Mail ………………...……….. : ehabmanse@yahoo.com
Mailing Address ………………. : 11 DR.Ahmed EL Khashab.Street – Nasr City
Cairo – Egypt
** Personal Data
Curriculum Vitae
** Academic Qualifications
- B. Sc. In pharmacy from Helwan university.
- Last year grade: Excellent – May 2004.
- General grade: Excellent.
- Premaster degree in microbiology from EL-Azher University.
** Experience
- Trained in Nile pharmaceutical company on summer 2003.
- Trained in pharmacy and in lab of liver & blood researches on summer 2004.
- From 2-2005 to 4-2008 worked in microbiology QC lab at Nile pharmaceutical company in fields of:
● Store sampling. ● Sterilitytest for parental products.
● Water analysis. ● Qualitative & quantative determination of endotoxin.
● Antibiotic assay. ● Antimicrobial preservative effectiveness test.
● Environmental air monitoring. ● Microbial limit test for raw materials and final products.
- From 5-2008 to 10-2012 participated in the startup of EIMC united pharmaceuticals that produce
sterile anticancer products beside other sterile & non-sterile pharmaceutical products, worked as
a microbiology supervisor in QC Lab, where performed the following duties:
● Writing Sops & validation method protocols for microbiological testing methods.
● Execute IQ, OQ & PQ with our validation dept for lab equipments (Autoclaves, Ovens, LAFs….etc).
● Training new analysts, reviewing them work & solving technical problems facing them.
● Execute validation of efficiency for Disinfectants & sterilants used in our Lab & in production area.
● Execute phase 1, 2 & 3 of water system qualification.
● Execute production tunnel & autoclave qualifications with our validation dept.
● Execute HVAC qualification with our validation dept & perform media fill trials.
● Execute sterility & LAL test method validation for parental products & perform both tests for them.
2. ●On 4-2011 trained byCape Code Companyin Barcelona on using PyrosKinetics flex, a newest kinetic
tube reader used for kinetic chromogenic & turbidimetric endotoxin detection techniques.
●One of the member team responsible for taking EMA GMP certificate, where EUP became certified
from EMA (European medicinal agency) to export sterile oncology products to Europe since 6-2011.
- From 1-2009 till now working in Advanced technology group (ATG) as a technical support manager
where responsible for:
● Training and solving technical problems facing customers of LAL reagents that ATG sell it.
●Training and solving technical problems facing customers on different microbiological tests required
it in pharmaceutical industries.
- From 11-2012, worked at Minapharm as a validation unit head where updated the protocols of
HVAC & thermal validation of autoclaves, SIP and ovens to comply with updated European
regulations.
- From 1-2013 to 9-2014, worked at Sunny pharmaceuticals as a validation section head where
responsible for:
● Planning the calibration and validation activities.
● Arrange with third party qualification labs to perform the required qualification tests.
● Writing and executing the validation & ongoing revalidation protocols for:
- Ampoules & vials washing machine performance qualification protocol.
- Thermal qualification protocol for Production Tunnel, Production & QC microbiology lab autoclaves.
- Thermal qualification for Steam sterilization in place applied for preparation, filtration & holding tanks.
- Hold time validation for sterilized tools, equipment & prepared bulks.
- Heat mapping for QC Lab incubators, refrigerators, stabilityrooms, media fill rooms & store area.
- HVAC performance qualification protocols for production, microbiology lab, dispensing & sampling
area.
- Fumigation performance qualification protocol.
- UV Pass through boxes performance qualification protocol.
- Compressed air & nitrogen systems performance qualification protocol.
- Cleaning validation protocol including riboflavin visualization test, Equipment product train matrix
& MACO limit determination, validation of clean & dirty hold times for clean in place and clean out
of place techniques.
- Coupon swab recovery validation protocol for worst case products selected from equipment product
train matrix.
- Balances annual calibration & qualification performance check.
- Media fill validation & ongoing confirmation protocol.
- Produced products process validation protocols.
● Participates in deviation & change control management systems.
● Participates in internal audit program & in risk management systems.
3. - From 9-2014 to 9-2016, working as a validation section head participating in startup of new
sterile & non-sterile hormone industry at Marcyrl pharmaceutical company where responsible
for:
● Writing URS for sterile hormonal facility & Non-sterile hormonal facility.
● Writing URS for needed Micro lab equipment.
● Writing URS for needed sterile area & Non-sterile area manufacturing equipment.
● Designing concept layout for Micro lab, Sterile & Non-sterile manufacturing areas.
● Delivering of needed quotations with URS-Gab analysis for Micro lab equipment and sterile area
manufacturing equipment.
● Developing of room data sheet for Micro lab.
● Reviewing concept design for Micro lab area.
● Reviewing concept design for manufacturing & store layout.
● Reviewing HVAC concept design.
● Reviewing all suppliers documents of DQ, FAT, SAT, IQ, Calibration, AFT & OQ protocols.
● Writing Validation master plan.
● Made required compounding & filling line modification with BOSCH Company.
● Writing the needed Performance qualification protocols for process utilities of HVAC, Pure media &
compressed gases.
● Writing the needed Performance qualification protocols for micro lab equipment of sterility test
isolator, autoclave & oven.
● Writing the Heat mapping protocols for incubators, refrigerators, media fill incubation room &
stability chambers.
● Writing the needed Performance qualification protocols for manufacturing equipment of ampoule
washing machine, tunnel, filling machine, SIP & autoclaves.
● Writing the needed Performance qualification protocols for isolators.
● Writing the needed Performance qualification protocols for VPHP Pass box & fumigation system.
● Writing the needed Performance qualification protocol for Media fill runs.
● Writing the needed Cleaning validation & Process validation protocols.
** Computer skills Microsoft Windows, Microsoft Office & Internet skills.
Finally, hopping that my qualifications meets your requirements.
Thanks in advance Ehab Mohamed