1. Name : MINA ADEL AZIZ BESADA
Address: 42, 595 Street from Seif Street, Sidi Bisher , Alexandria
Contact numbers: +201282882935, +2035279816
Email: mina_adel1@hotmail.com
SUMMERY:
• Profile: Male, 30, married
• Nationality: Egyptian
• Current Location: Alexandria, Egypt.
• Current Position: Q.C Mgr
Marketing & sales team
Purchasing technical team member
Regulatory Affairs Team Member
R& D team Member
• Company: Pharmaplast S.A.E
*Education: Bachelor of Science & education from the department of
physics & chemistry- Alexandria University.
•
Objective
Seeking to further my Career, utilizing the skills and experience I have
acquired in the medical device manufacturing field. specially in
technical side.

2. Highlights:
• Proven ability to align, influence subordinates to work toward
common goals with Excellent organizational and job-task planning
skills.
• Talented to create a good motivating work environment and motivate
myself as well as motivating others.
• Resourceful enough to learn from situations and my passion is self-
development.
• Work well collaboratively within a team setting demonstrated
excellent communication skills.
• Hard worker can work under pressure to meet deadlines with lateral
thinking strategies for resolving issues.
PROFILE
Highly accomplished and innovator leader with more than 9 years of
extensive accomplishments with proven ability to plan , lead
,organize ,control and Motivate people to achieve organizational
objectives as a team.
EXPERIENCE:
1-from 9-2002 -9-2003
• Job title: chemist (Q.C inspector) in quality control lab
• Reporting to : Q.C Mgr
• Job activates :
1) Raw material inspection including visual and chemical /physical
testing for all entire materials.
2) In process/final inspection for converted materials including all
visual/chemical /physical testing
3) Waste percent calculation,
4) Documentation and filing of all inspection records in designated
forms

3. 5) Reporting to Q.C Mgr/production Mgr in case of any nonconformity
highlighted within the following inspection steps
6) Ensure and follow up that All working stuff and manufacturing
facility applying the needed measures for good manufacturing practice
7) Applying international standard (attached reference sheet).
2- From 9-2003 to 10-2004
• Job title: Microbiologist at the Microbiology lab
• Reporting to : Q.C Mgr
• Job activates :
1) Microbiological testing for raw material
2) Microbiological testing for semi finished products & finished
products
3) Sterility testing for sterilized finished products
4) Environmental controls including measuring the bioburden for
floor, inlet Air ,machine surface and cylinders, walls ,workers
finger print ,worker garments ,particles counts, Air volume and
different pressure ,temperature and relative humidity monitoring.
5) Ensure and follow up that all working stuff follow the entering
and exit good practices to minimize the risk of cross
contamination .
6) Validation of critical zones where higher risk of bioburden
could be present
7) Applying international standard (attached reference sheet).
8) Reporting to Q.C Mgr/production Mgr in case of any
nonconformity highlighted within the following inspection steps
2- From 10-2004 to 12-2005
• Job title: Head of sterilization department
• Reporting to : Q.C Mgr /production Mgr
• Job activates :
1) Receive the sterilization order and fix the sterilization weekly
plan based on orders priorities ,manage the Microbiologist
&operators activates via weekly plan

4. 2)
2)Follow up the sterilization activates including precondition
,contact phase ,degassing phase
3) Review all sterilization parameters data till the process and after
the end of the process
4) Follow up the gas indicator /BI indicators testing include growth
promotion testing , blank testing
5) Ensure and follow up with the sterilization team the filing and
documentation of records in form of batch records to ensure
traceability
6) Releasing of sterilized goods after reviewing the testing results of
sterility
7) Follow up with maintenance dept the monthly check for the
sterilization cell
8) Fix the purchasing plan for the ETO gas and Nitrogen gas also the
lab equipment
9) Follow up the yearly validation work to ensure the cell
sterilization parameters still valid and complying to the standard.
4- From 1-2006 to 1-2007
• Job title: Quality control Mgr ./ R&D Team member
• Reporting to : Technical Mgr /CEO
JOP DESCRAPTION:
aims to ensure that the product or service an organization provides is
fit for purpose and meets both external and internal requirements,
including legal compliance and customer expectations., coordinates
the activities required to meet quality standards.
Also monitor and advise on the performance of the quality
management system and produces data and report on performance,
measuring against set indicators.
Liaise with other managers and staff throughout the organization to
ensure that the QA system is functioning properly. Where
appropriate, advise on changes and their
Implementation and provides training, tools and techniques to enable
others to achieve quality.

5. Job activities:
Since maintaining quality demands adaptation to customer
expectations, a variety of measures to place quality at the heart of an
organization. These include management systems such as ISO 9001-
2008, 13485-2003 .Medical directive 2007/47/EC, philosophies such
as Total Quality Management, and methodologies such as
Continuous Improvement.
 1-promoting quality achievement and performance improvement
throughout the organization;
 2-setting Compliance objectives and ensuring that targets are
achieved;
 3-maintaining awareness of the business context and company
profitability, including budgetary control issues;
 4-assessing the product specifications of the company and its
suppliers, and comparing with customer requirements;
 5-ensuring compliance with national and international standards and
legislation;
 6-considering the application of environmental and health and safety
standards;
 7-agreeing standards and establishing clearly defined quality methods
for staff to apply as to define quality procedures in conjunction with
operating staff;
 8-setting up and maintaining controls and documentation procedures;
 9-identifying relevant quality-related training needs and delivering
training;
 10-collating and analyzing performance data and charts against
defined parameters;
 11-ensuring tests and procedures are properly understood, carried out
and evaluated and that product modifications are investigated if
necessary;

 12-supervising technical staff in carrying out tests and checks;
 writing technical and management systems reports

6.  13-bringing together staff of different disciplines and driving the
group to plan, formulate and agree comprehensive quality
procedures;
 14-persuading reluctant staff to change their way of working to
incorporate quality methods;
 15-liaising with customers' auditors and ensuring the execution of
corrective action and compliance with customers' specifications;
 16-establishing standards of service for customers or clients;
 preparing clear explanatory documents such as customers' charters;
 17-Monitoring performance by gathering relevant data and producing
statistical reports.
Activities and experience in R&D
1- Start up a (hydro -gel) plasters dept. and have a good knowledge
about hydro gel production and formulation (burn gel -3D structure
gel –Amorphous gel – sanitizer gel-highly absorption gel). Which
used in modern wound care as class IIb Products.
2-Have a good knowledge about water purification system .including
micro biology tests and chemical tests.
3-have a good knowledge about irradiation sterilization with gamma
ray & beta ray (cyclotron) process and validation requirement.
4-have a good knowledge about adhesive coating line (in medical
application).(solvent base adhesives –hotmelt adhesive –water base
adhesives /gravure coating )
5- Participate in developing many of medical devices together with
R&D team
 hydrocolloid formula for modern wound care class IIb medical
devices
 silver foam, class IIB medical device
 silver gel, IIB medical device
 silver colloid, IIB medical device
 salicylic acid patches formulation class III medical
 Phamatull dressing class IIB medical device
 Pharmajelly net class IIb medical device
 PharmaTull POVI and Iodine ointment class III products


7.  participate with R & D team work in extrusion line project
installation, including analysis, contact chemical supplier
 Good Knowledge about wound pad manufacturing, (Raw material
outsourcing, formulation, process requirement)
 Good Knowledge about wound pad impregnation manufacturing,
(Raw material outsourcing, formulation, process requirement)
 participate with R & D team to develop our new folding drapes
project (Raw material outsourcing, testing requirement, process
requirement)
 polyurethane pre-polymer manufacturing /testing
 cold seal/heat seal coating
 film lamination using Pu based adhesive
 patient search and developing protocol planning
5- From 1-2007 to Now
• Job title: extended to include other duties
A) sales and marketing team member
B) Regulatory affairs
C) Purchasing and Evaluation of new supplier
Reporting to: Technical Mgr /CEO
Experience in sales and marketing:
 Achieves marketing and sales operational objectives by contributing
marketing and sales information and recommendations to strategic
plans and reviews; preparing and completing action plans;
implementing production, productivity, quality, and customer-service
standards; resolving problems; completing audits; identifying trends;
determining system improvements; implementing change.

8.  Meets marketing and sales financial objectives by forecasting
requirements; preparing an annual budget; scheduling expenditures;
analyzing variances; initiating corrective actions.
 Determines annual and gross-profit plans by forecasting and
developing annual sales quotas for regions; projecting expected sales
volume and profit for existing and new products; analyzing trends and
results; establishing pricing strategies; recommending selling prices;
monitoring costs, competition, supply, and demand.
 Accomplishes marketing and sales objectives by planning,
developing, implementing, and evaluating advertising, merchandising,
and trade promotion programs; developing field sales action plans.
 Identifies marketing opportunities by identifying consumer
requirements; defining market, competitor's share, and competitor's
strengths and weaknesses; forecasting projected business; establishing
targeted market share.
 Improves product marketability and profitability by researching,
identifying, and capitalizing on market opportunities; improving
product packaging; coordinating new product development.
 Sustains rapport with key accounts by making periodic visits;
exploring specific needs; anticipating new opportunities.
 Provides information by collecting, analyzing, and summarizing
data and trends.
 Protects organization's value by keeping information confidential.
 Updates job knowledge by participating in educational
opportunities; reading professional publications; maintaining personal
networks; participating in professional organizations.
• Accomplishes marketing and organization mission by completing
related results as needed.
Experience in regulatory affairs

9. • ensuring that a company's products comply with the regulations of
the Medicines and Healthcare products Regulatory Agency
(MHRA) and current Medical directives
• keeping abreast of international legislation, guidelines and
customer practices;
• collecting and collating a wide range of information;
• keeping up to date with a company's product range;
• developing and writing clear arguments and explanations for new
product licenses and license renewals;
• preparing submissions of license variations and renewals to strict
deadline
• monitoring and setting timelines for license variations and renewal
approvals;
• working with specialist computer software and resources;
• writing clear, accessible product labels and patient information
leaflets
• planning and developing product trials and interpreting trial data;
• advising scientists and manufacturers on regulatory requirements;
• project managing teams of colleagues involved with the
development of new products;
• undertaking and managing regulatory inspections;
• reviewing company practices and providing advice on changes to
systems;
• liaising with, and making presentations to, regulatory authorities
• negotiating with regulatory authorities for marketing
authorization;
• Specifying storage, labeling and packaging requirements.
• a part of team work which pass the audit and get ISO & CE mark
& BRC certification for years from 2002 to 2012
• Reviewing OBL Agreements with costumers including each party
duties and obligation.
Experience in purchasing:

10. 1-Responsible for Raw material and chemicals purchasing for any
new developed products including quality evaluation ,price
negotiation ,delivery agreement where I am the key person in
connect with the multinational companies' .like BASF, EXXON
chemical, Shell, DOW...Etc
2-Prepare purchase orders and send copies to suppliers and to
departments originating requests.
3-Determine if inventory quantities are sufficient for needs, ordering
more materials when necessary.
4-Respond to customer and supplier inquiries about order status,
changes, or cancellations.
5-Perform buying duties when necessary.
6-Contact suppliers in order to schedule or expedite deliveries and to
resolve shortages, missed or late deliveries, and other problems.
7-Review requisition orders in order to verify accuracy, terminology,
and specifications.
8-Prepare, maintain, and review purchasing files, reports and price lists.
9-Compare prices, specifications, and delivery dates in order to
determine the best bid among potential suppliers.
10-Track the status of requisitions, contracts, and orders.
11-Calculate costs of orders, and charge or forward invoices to
appropriate accounts.
12-Check shipments when they arrive to ensure that orders have
been filled correctly and those goods meet specifications.
13-Locate suppliers, using sources such as catalogs and the internet,
and interview them to gather information about products to be ordered.
14-Maintain knowledge of all organizational and governmental rules
affecting purchases, and provide information about these rules to
organization staff members and to vendors.
15-Monitor contractor performance, recommending contract
modifications when necessary.
Other duties:
One of the marketing team participate Medica fair ( Messe Düsseldorf )
through years from 2008-2014.

11. Good experience in supply chain ,starting from raw materials till the
shipping
SKILLS:
1) COMPUTER SKILLS:
1- Good Knowledge of windows operating system
2- Microsoft office. (Word-excel )
3- Good internet research (research work).
5-power point presentation
2- LANGUAGE SKILLS:
1-Good command of English (written & spoken)
2- Arabic (mother tongue)
Training:
1- Special training in adhesive and sealants in pharmaplast by
National Starch co.
2-regulatry affairs (how to apply CE mark for medical product)
course by Midvisor group
3- Regulatory affairs & marketing course by IMC center
6- Certified from the Atomic power authority for protection from
ionized Radiation
7-Extrusion process and trouble shooting from Alexandria plastic
research center.
7- lead audit course for iso 9001 by SGS Egypt

12. REFRENCES TO BE FURNISHED UPON REQUEST
Mina Adel Aziz