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. ● Sterility test 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.

● On 4-2011 trained by Cape Code Company in 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, stability rooms, 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.

- 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