Quality Assurance Manufacturing

Bassnt Mohamed Yasser

**-* ** ****** * compound el Waab

street,Doha,Qatar-Tel: 77211448

E-mail: ************@*****.***

Objective

To create a long-term career with a well established reputable

organization where I can gain more experience and extend my knowledge, as

well as to provide a clear career path and future professional development.

Education

. Secondary Schools:

Notre Dame Des Apotres Language School

. BSc. of pharmaceutical Science Cairo University ( June 2007)

Grade: very good with honor.

. TQM certified (ISO 9000 & 14000 and quality management system

certified).

. Quality Master from Arab academy for science and technology 2013

(thesis project "utilizing lean manufacturing tools to enhance quality

of sterile pharmaceutical products").

. GSK Green Belt Six Sigma certified.

. Level1 -Level2 Certified Auditor.

Courses:

1: GMP, GLP & Validation.

2: Risk Managment.

3: Time managment.

4: Communication skills.

5: Enviromental Health & safety several Courses

(first Aid, Fire Fightinig,Safety Symbols)being one of the EHS Committe.

6:Problem solving.

7. Negotiation skills.

8.Sterile area workshop (Bernard Castle GSK UK)

Computer Skills

o Access to Internet and using all search engines.

o Know Skillfully how to use (Windows series - Word - Excel & power-

point)

Language Skills

Languages Reading Writing Speaking

English Excellent Excellent Excellent

French good good good

Personal Skills

. Analytical thinking & logical solutions for problems.

. Communication skills.

. Presentation skills.

. Enthusiastic hard working dedicated and open to learn new skills.

. Motivated, enjoy having social relations and great respect to all of

my friends and teachers.

. Quick learner / Analytical mind.

. Enjoying team work.

Experience

> Working - Qatar Unversity-Qatar:

(From: March 2014 till now)

Position: Research associate.

> Experience of research conduction, including fieldwork and creating

interview content

> Experience of analysis and writing up of research findings and

preparing project documents using SPSS analysis program and minitab.

> Reports writing and papers preparation.

> Designing and conduction of surveys and analyzing their outcomes

> Working - GlaxoSmithKline Egypt:

(From: July 2011 till now)

Position: section head for quality assurance and validation

department.

Providing Technical routine and non-routine work which

includes:

Routine verification and periodic validation & Calibration of all kind of

instruments forms either as finished product or stability QC lab. Or

production value streams.

Carrying out periodic qualification for sterile area for both Lactam and

non-Lactam areas including environmental control, Media fill simulation,

Air system qualification, Tunnel & Autoclave Verification as well as

facility qualification and area classification .

Performing Performance qualification for all production machines and

periodic re-validation.

Performing process validation for all GSK products by process technical

risk assessments and researches to identify process gaps using prolem

solving techniques s FMEA, gap analysis, GEMBA, Kaizen .

SOPs writing and GAP analysis for GSK Quality management system & WHO

guidelines as well as Cleaning & process validation and Site Validation

Master Plan formulation for the whole site.

Change Control management for all GSK changes (HR, Financial, Quality,

production, procurement, planning & regulatory).

Cleaning validation for all manufacturing machines and instruments

including protocoling, planning and swapping till finally analysis and

reporting.

GSK sterile area expert dealing with facility design review as well as area

classification and environmental system viable and non-viable control.

> Working - GlaxoSmithKline Egypt:

(From: September 2009 till now)

Position: Q.C. Analyst in Finished Products Section

Providing Technical routine and non routine work which

includes:

< Routine analysis of all kind of dosage forms either as finished product

or stability ones using all kinds of analytical equipment as HPLC, UV,

TOC etc.

< Analysis of new dosage forms and new products with analytical methods

verification.

< Analysis of new Active Constituents and writing of all analytical and

validation reports in API project.

< Analysis of Cleaning Validation Swaps.

< SOPs writing and GAP analysis.

< Full awareness with GLP and LIMS

< All Chemicals Check up and Chemical inventory in Laboratory and Ware

house including Purchase orders of all solid and liquid chemicals

< Acting as Laboratory First aider

< Calibration of all Chemical Equipments (Balances,Karl Fisher,

Dispensators, Dissolution, PH meter).

< Chemical lab analysis and HPLC integration expert (with wide knowledge in

HPLC integration techniques, Stationary phase ( columns ) type and

function, mobile phase preparation and validation).

Drug Manufacturing researches providing Business solutions:

During Drug manufacturing different manufacturing problems as well as

regulatory problems that need solutions and stated in research summary card

some researches done on Drugs to enhance its activity or improve its

manufacturing capability or to comply with MOH regulations.

> Working -SEDICO Pharmaceutical Company Egypt:

(From: March 2008-TO: September 2009)

Position: from March 2008 till January 2009 as R&D Specialist

And From January 2009 till September 2009 as Validation and

methodology Specialist

< Providing Technical work which includes:

< Formulation of new products of all Dosage forms.

< Customizing and developing of all Analytical Validation Reports and

Protocols.

< Formation of New Methods of all Dosage Forms .

< Cleaning Validation (taking production swaps and analysing them then

developing their validation reports).

< Standards check-up and Purchase as well as preparation o in house

standards.

> Working -Abdel Halim`s pharmacy Egypt:

(From: July 2007-TO: July 2010)

Position: retail - Pharmacy Manager for Faisal Branch

< Providing patients with all the help regarding OTC drugs dispensing.

< Formulation of some Drug formulas (lotions and antiseptics).

< Carrying out all financial issues .

< Dealing with all distribution offices and drug companies .

< Providing patients with a great experience regarding the Drugs active

ingredients and their adverse reactions.

< Extensive Knowledge of Medicine, compounds and their dosage.

< Having good research and communication skills.

< Advance Knowledge in Medical terminology and concepts.

< Familiar with numbers with excellent analytical skills.

< good organizational and problem solving skills.

Researches Summary Card

Drug Formula Existing Research performed Impact on business

problem result continuity

Chewable Dissolution Change in the Enhancement of

Tablets exceeding USP manufacturing compressibility

limit of not composition of parameters of this drug

more than 85% this drug by and achieving successful

assay in 30 removal of sugar dissolution of assay

minutes and substitution limit between 98-100 %

by aspartame to in 15 minutes

enhance

dissolution as

well as addition

of disintegrate as

CMC

Injection Poor Change of improvement of

suspension uniformity manufacturing uniformity results by %

results and process to avoid of 100 % uniform assay

inadequate human interference as well as no sterility

method of by automation of failure for 50

sterile the process using successive batches

filling due to sterile auto

bio-burden clavable tanks

introduced by rather than

human preparation flasks

interference

Oral Lumps are Changing active Enhancement of drug

suspension performed material particle suspension within the

after drug size after sieve suspending agent and

re-constitutio analysis performed excellent assay results.

n as well as to avoid different

failure of particle sizes and

assay results obtain micronized

API

Oral tablets Capping of Changing of the Enhancement of drug

tablets during manufacturing compressibility and

compression process from decrease of batch waste

direct compression from 15 % to 3%

to slugging

suppository Low assay Change of improve assay results to

results manufacturing be between 98% to 102%.

steps to decrease

amount of water

and change its

addition to be

after preparation

cool down due to

supp. Base heat

effect

Creams Inability to Change of the Decrease injection time

analyse the mobile phase from 22 minutes to 8

product due to concentration minutes with perfect

no peak between aqueous peaks separation.

separation and organic phase

during HPLC to improve peaks

analysis resolution and

required injection

time as well as

use of column

symmetry C 18

instead of C8 to

enhance peaks

separation

Projects Summary Card

Project name Existing Project nature Impact on business

problem continuity

Sterile Sterile area Sterile area compliance with WHO

manufacturing classification upgrade to adjust guidelines.

area upgrade against WHO area Securing hole Sterile

guideline classification to processing with proper

annex 6 and include crimping area classification .

sterile area and its Differential pressure

filling area background to and CFM (air flow)

Human Grade D with LAFs adjustment to secure

interventions (laminar air flow) absence of any area

to exposed installation to containment.

product secure Grade A

during crimping as

well as

installation of

RABs (restricted

air barriers) and

glove ports for

exposed sterile

product

manipulation and

decrease of human

interventions

which show a great

risk to product

sterility .

Cleaning Cleaning Validation of cleaning validation

validation validation for cleaning analysis of all

project all drug parameters for materials residues .

products each product after

cleaning full study of each Cleaning validation

methods to drug active methods creation of

ensure absence ingredient to different APIs (active

of any carry define (LD50, product ingredients) to

over between maximum determine LOD (limit of

different therapeutic daily detection ) & LOQ (limit

products dose, minimum of quantitation).

manufactured therapeutic daily

on the same dose, drug Validation of required

machines solubility in cleaning parameters per

water, and MSDS each active ingredient

(material safety nature.

data sheet) of all

detergents to

determine the

maximum allowable

carryover of each

drug and each

detergent to

secure product

safety and

quality.

HPLC (High Column Injection of Securing analyst safety

Performance regeneration organic phase in by decreasing

liquid by organic some columns to utilization of toxic

chromatography phase extend their life chemicals as

) Stationary injection and time, as well as acetonitrile or

phase columns mobile phases Methanol.

regeneration inversion in validation to Cost reduction by

and mobile addition to extend their life decreasing chemicals

phase validation of up to 3 months by utilization by about 40

validation freshly defining valid % annually.

prepared storage conditions Cost reduction by

Mobile phases and comparing to decreasing column

up to 3 months the system purchase by 30 %

suitability annually.

injections

Personal Information

o Date of Birth: 1st of January 1985.

o Place: Egypt.

o Religion: Muslim.

o Nationality: Egyptian.

o Marital state: Married

o Governmental Obligation: Canceled

o Having Qatari residency

All references will be furnished upon request.

Contact this candidate