Basic Info

Sherif salama

7 years

Sharqia, Egypt

Bachelor's Degree

Experienced

Work Experience

Quality Assurance Section Head at IDH

Experience Details

Quality Assurance Section Head

Quality

Experienced (Non-Manager)

a) Plan, establish, execute, measuring and continuously improve both of calibration & risk
management systems to fulfill accreditation standard “CAP, College of American
Pathologists”.
b) Oversees performance of laboratory staff in compliance with accreditation standards, safety
and environmental regulations, and other applicable requirements.
c) Manages quality monitoring, improvement programs by following ongoing maintenance of
professional competency through providing appropriate education and training.
d) Maintains and/or oversees maintenance of test equipment and instruments to ensure
accuracy and efficient performance and review preventative maintenance and/or daily
cleaning of laboratory equipment, work areas and non-disposable apparatus are performed.
e) Report to the quality manager the problems with Quality Control and/or instrumentation;
when reagents and consumables require ordering.
f) Assists in Preparation of periodic reports of quality issues, trends, findings, and corrective and
preventive actions.
g) Prepares reports of adverse reactions, deviations in the manufacturing process,
nonconforming products and services, and customer complaints.
h) Develops and produces Standard Operating Procedures (SOP’s) which meet the
regulatory/accreditation standard.
i) Completes and submits the required documentation for accreditation process.
j) Monitors appropriate systems for specimen collection, processing, testing, recording of results,
and quality control.
k) Liaison with suppliers, service providers and external parties for quality issues.
l) Review hygiene programme and ensure proper implementation.


Company Details

IDH (multinational)

Egypt

More than 1000 employees

Healthcare and Medical Services

N/A

Nov 2016 to present (1 year 1 month)
QA supervisor at Otsuka

Experience Details

QA supervisor

Quality

Experienced (Non-Manager)

I. From 1/7/2015 till now at “OTSUKA” multinational company for Pharmaceuticals Industries as quality assurance (QA) supervisor.
a) Lead & supervising team responsible for handling the following processes:-
Deviation, CAPA, change control, complaint, internal audit, risk assessment and ensure effectiveness of these processes by continues measuring its operation against standards, guidelines and SOPs through KPIs and continually improving and updating them.

b) Preparing semiannual and annual reports including our coming priorities according to the statistical analysis for data collected from previous processes to present it to top management based on which the new objectives will be assigned and implemented.

c) Participate in coordinating and following external audits conducted by Egyptian and Sudan MOH and other customers as GSK, , MUP, Sanofi Aventis , Pfizer,…..

d) Participate in problem solving and root cause analysis for raised deviations.

e) Training all staff on previous processes through effectively prepared training materials as power point, work shop and other training tools then evaluate and assess training impact in reality.


Company Details

Otsuka (multinational)

Cairo, Egypt

501-1000 employees

Pharmaceuticals

N/A

Jul 2015 to Oct 2016 (1 year 3 months)
QA senior at Otsuka

Experience Details

QA senior

Quality

Experienced (Non-Manager)

a) Controlling and supervising packaging area
b) Coordinating deviation and CAPA processes
c) Prepare SOPs
d) Participate in internal audit team


Company Details

Otsuka (multinational)

Cairo, Egypt

501-1000 employees

Pharmaceuticals

N/A

Jul 2012 to Jun 2015 (2 years 11 months)
QA inspector at Otsuka

Experience Details

QA inspector

Quality

Experienced (Non-Manager)

a) Inspect production lines/areas for GMP compliance and other quality standards.
b) (Dispensing review and control, IPC in sterile area including preparation and filling process)
c) Check sampling and testing of product during manufacturing, filling or packaging
according to approved sample plans.
d) Complete and maintain quality and production records according to GMP and
other quality standards.
e) Approves incoming materials & in-process production & finished products by
Confirming specifications, conducting visual and measurement tests, rejecting and
returning unacceptable materials.
f) Check the facility and personnel hygiene and sanitation status.
g) Doing integrity test for filters, particle count test by met one device, smoke test,
Dop test...…
h) Controlling media fill test.
i) Controlling tablet IPC tests as friability, disintegration, hardness, thickness and weight
variability.
j) Controlling SIP for machines by pure steam and for sterile rooms by Dry Fog Tech
or by Formalin/Ammonia Tech.


Company Details

Otsuka (multinational)

Cairo, Egypt

501-1000 employees

Pharmaceuticals

N/A

Jul 2010 to Jun 2012 (1 year 11 months)
Medical representative at Abbotte

Experience Details

Medical representative

Marketing/PR/Advertising

Entry Level

responsible for marketing of blood-glucose monitoring system “FREE STYLE”
in hospitals and private clinics


Company Details

Abbotte (multinational)

Sharqia, Egypt

More than 1000 employees

Medical Devices and Supplies

N/A

Jun 2009 to Jun 2010 (1 year)

Achievements


Updating Deviation , CAPA , Change control SOPs to include KPIs for measuring processes performance and passing audits of GSK , Sudan MOH


Letter of Appreciation from Otsuka for me as member of the team who was responsible for the planning , executing and operating the new ampoule project which involve adding two lines for 5 ml and 25 ml WFI ampoules. My role in the project from the quality assurance view is to managing process validation including media fill process and normal production process and also controlling compliance of produced units or ampoules with specifications (volume, weight , thickness, crack, leak ,...) , preparing trends, control charts , other graphs and statistical tools and also qualification of the new loop which extended to the preparation and filling of the new project


Education

College Diploma in Total quality management

Education Details

College Diploma

Total quality management

AUC, Egypt

A / Excellent / 85 -100%

Diploma of TQMincluding the fo

N/A

AUC
2014 - 2015
College Diploma in Microbiology

Education Details

College Diploma

Microbiology

Suez Canal University, Egypt

C / Good / 65 - 75%

N/A

N/A

Suez Canal University
2008 - 2009
BSC in Microbiology

Education Details

BSC

Microbiology

Suez Canal University, Egypt

C / Good / 65 - 75%

N/A

N/A

Suez Canal University
2003 - 2007
High School - Other

High School Details

Other

HEHIA SECONDARY SCHOOL

Egypt

2003

A / Excellent / 85 -100%

N/A

HEHIA SECONDARY SCHOOL
2003

Certifications

TQM
Apr 2015

Certificate details

TQM

Apr 2015

90 out of 100

N/A

600131232

AUC

N/A

Certificate details

Lead Auditor ISO FSSC (22000 , TS 22001)

May 2016

N/A

N/A

N/A

SGS Accredited from IRCA

N/A

Training and Courses

Training/Course Details

Leadership

Nov 2015

Otsuka

N/A

GMP at Otsuka
Apr 2011

Training/Course Details

GMP

Apr 2011

Otsuka

N/A

Training/Course Details

pharmacovigilance

Apr 2011

Otsuka

N/A

This profile is fresh!
Last update 2 days ago.

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Profile Skills and Keywords

AbbotteArabicAudit ManagementBaldrigeCommunicatorCreativeDeliberationDeviation & CAPADocumentationEnglishGMPHACCPHard WorkerHealthcare And Medical ServicesHonestIDHISO 14001ISO 22000ISO 9001/2008Lead Auditor ISO FSSC (22000 , TS 22001)LeaderLeadershipMarketingMedical Devices And SuppliesMedical RepresentativeMicrobiologyMicrosoft ExcelMicrosoft PowerPointMicrosoft WordMinitabOtsukaPerseverancePharmaceuticalsPharmacovigilancePlannerPlanning For Top QualityProject ManagementQA InspectorQA SeniorQA SupervisorQuality AssuranceQuality Assurance Section HeadQuality ControlSix SigmaTQMTime RespectTotal Quality Management

Self-assesed Skills

Languages

Arabic

Arabic

: Fluent

: Fluent

: Fluent

: Fluent

English

English

: Fluent

: Fluent

: Advanced

: Fluent

Tools and Technologies

Microsoft Word

Microsoft Word

: Advanced

: Extreme - I love it!

:

More than 7 years

Microsoft Excel

Microsoft Excel

: Advanced

: Extreme - I love it!

:

More than 7 years

Microsoft PowerPoint

Microsoft PowerPoint

: Advanced

: Extreme - I love it!

:

More than 7 years

Minitab

Minitab

: Advanced

: Extreme - I love it!

:

1-3 years

Fields of Expertise

Deviation & CAPA

Deviation & CAPA

: Expert

: Extreme - I love it!

:

5-7 years

Planning for top quality

Planning for top quality

: Expert

: Extreme - I love it!

:

1-3 years

ISO 22000

ISO 22000

: Expert

: Extreme - I love it!

:

1-3 years

six sigma

six sigma

: Advanced

: Extreme - I love it!

:

1-3 years

ISO 9001/2008

ISO 9001/2008

: Advanced

: Extreme - I love it!

:

5-7 years

ISO 14001

ISO 14001

: Advanced

: Extreme - I love it!

:

1-3 years

Project management

Project management

: Advanced

: High

:

5-7 years

documentation

documentation

: Advanced

: High

:

5-7 years

HACCP

HACCP

: Advanced

: Extreme - I love it!

:

1-3 years

Audit management

Audit management

: Advanced

: Extreme - I love it!

:

3-5 years

Baldrige

Baldrige

: Intermediate

: Medium

:

Less than 1 year

Key Skills

Leader, Planner, Communicator, Hard worker, Creative

Online Presence

https://www.linkedin.com/profile/view?id=AAIAABE2XjEBKZG-YfrBCtSakgzcFRCNSxvr0Ss&trk=nav_responsive_tab_profile

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