Yara Al Mouti

Email: yara.almouti@agonacademy.com
Ph: +962 79 9965653

Core Competencies
Quality Assurance Risk Management Six Sigma
Project Leadership Process Optimization Strategic Planning
Compliance Process Improvement

Key Achievements

- Successful Management for several Quality systems establishment )cGMP, and GSDP)

- Successful management of several compliance projects for number of pharmaceutical industry

manufacturers, to obtain cGMP certifications from different authorities, like the EU Union
countries, Sandi FDA, Jordanian FDA and the GCC.
- Successful management of several GSDP compliance projects for number of drug stores.

- Successful management of several Gap Assessment and Diagnosis projects and provide
detailed Quality systems diagnosis reports and detailed task plans.

- Successful initiation and management of number of training workshops and conferences that
included participants from the region and speakers from all around the world.

- Development of Strategic plans for some of the companies I worked with and followed up the
progress of the plans and proposed the changes in methodology for the projects that were not
running efficiently.

- Development of Plans and follow up the setting of turnkey pharmaceutical manufacturing

facilities projects, from early design phases, equipment\contractor’s selection and purchasing,
installation, commissioning and validation.

- I developed building capacity programs for my clients (pharmaceutical manufacturers and drug
stores) to enhance the employee’s caliber and technical knowledge.

Educational Qualification:

B.Sc IN CHEMICAL ENGINEERING 1994-1999

Al-Balqa University-Amman College for Technical Engineering
Amman-Jordan

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Professional Experience
Agon ( Consultancy & Academy)
Duration Involved January 2010 till present
Role CEO and Projects Director
Responsibilities - Senior consultant of Industrial companies for the compliance diagnosis and system
establishment, the systems include but not limited to:
1. cGMP and GLP requirements
2. ISO (9001, 22000, 22716, 13485)
3. GSDP requirements.
4. Six Sigma
- Trainer in the following subjects:
1. GMP Compliance Overview
2. ISO 22716 (GMP Safety)
3. Risk Managment
4. Process Control
5. Quality Control
6. Process Optimization
7. Good Documentation Practices
8. Good Storage and Distribution Practices
9. Validation and Qualification:
a- Cleaning Validation
b- Process Validation
10. Statistics in Quality

- Initiation and design of business scenarios for the clients to fulfil their
requirements and design a tailor-made Consultancy solutions, programs and
Training.

Naratech Pharmaceutical Consultancy

Duration Involved January 2008 till January 2010
Role GCC Project manger – Project Manager
Responsibilities - Project management of pharmaceutical manufacturer’s compliance diagnosis and
system establishment according to cGMP, ISO 22716 (GMP safety) and GLP
requirements, to enable companies to register in EU and the GCC.
- Project Management of drug stores and cold products store diagnosis and system
establishment according to GSDP requirements.
- Follow up the projects from initiation and marketing phases through the
conceptual design phase, kick off meeting, carrying out the diagnosis study, task

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plans initiation and implementation, follow ups and coordination with contractors,
suppliers and client, supervise the implementation process up to the inspection
phase and project close up.

- Initiation and design of the training department strategy every year, from the
suggesting of the workshops and conferences, initiation of the courses, securing
the sponsorship (if needed) till the successful delivery of the workshop and
conference.
- Initiation and design of business scenarios for the clients to fulfil their
requirements and design a tailor-made programs and solutions.

Free Lancer – Self Employed

Duration Involved October 2005 till August 2006
Role Project manger
Responsibilities - Project management of pharmaceutical manufacturer’s compliance diagnosis and
system establishment according to cGMP and GLP requirements, to enable
companies to register in EU and GCC countries.
- Establish and follow up the Quality system for major pharmaceutical and
veterinary drug manufacturers to ensure their compliance to the EU regulations.
- Help under establishment companies by reviewing the conceptual designs, process
flow, personnel and material flow diagrams, procurement of utilities and
machinery and establishing the quality system.
- Initiation and design of business scenarios for the client’s needs to fulfil their
requirements and design a tailor-made programs and solutions.
Total Innovative Solutions
Duration Involved March 2005 till October 2005
Role Project manger
Responsibilities - Project management of pharmaceutical manufacturer’s compliance diagnosis and
system establishment according to cGMP and GLP requirements, to enable
companies to register in EU and GCC countries.
- Establish and follow up the Quality system for major pharmaceutical and
veterinary drug manufacturers to secure their compliance to the EU regulations.
- Help under establishment companies by reviewing the conceptual designs, process
flow, personnel and material flow diagrams, procurement of utilities and
machinery and establishing the quality system.
- Initiation and design of business scenarios for the client’s needs to fulfil their
requirements and design a tailor-made programs and solutions.

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Advanced Pharmaceutical Industries (HIKMA at later stage)
Duration Involved May 2002 till March 2005
Role Quality and Validation Engineer
Responsibilities - Also I was involved in developing quality control methodologies and tests related
to in process testing and finished product testing, and I was also involved in raw
material sourcing process.
- As the firm was preparing to be registered in the European Union, I
performed as part of the registration steering committee which guided all the other
departments toward a comprehensive quality system, and also I performed as a
part of the validation steering team, I designed, supervised, wrote and executed
validation protocols in the following areas:

* Building and facility ,water treatment unit, HVAC unit, Utilities, Labs
equipments, Production equipments, Process validation, Cleaning validation,

- As part of the quality assurance section I designed and performed Internal

Quality Audits that covered all the departments and all the quality requirements.

- Researched for, developed and performed a statistical treatment of the data out of
the process validation, analysis data results treatment, Sampling plans design.

Chemical and Mining Co.

Duration Involved Sep 1999 till May 2002
Role Quality Engineer
Responsibilities - Monitoring and controlling of lines and process for slurry explosives according to the
quality and safety requirements.

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