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Curriculum Vitae

1-Personal Data : Name: Helmy Ismail El-Sayed Afyfy.Date of Birth: 10 Aug.,1970Nationality: Egyptian. Military service: Exempted.Address: 21 El-Geohary Street, Zeiton, Cairo –Egypt.Tel.No. / e.mail address : 0224508306 or 0122852338 / helmyismael0@gmail.com Marital Status: MarriedHobbies: Reading, sports and music.

2-Academic qualifications/ Certification: Living Safety facilitator certification by GSK Year 2015 “Duration of study Four months ” Six Sigma Green Belt Certification – Year 2008 “Duration of study One year ” Post graduate degree "Diploma of business administration, Faculty of Commerce, Ain shams

University, 2007 with grade Very Good “ Duration of study Two years” Post graduate degree “Master degree of microbiology , Faculty of Science , Ain Shams

University, 1997 “Duration of study Four years” Bachelor of Science in “ Microbiology / Chemistry “ with grade “Very good”, Faculty of Science ,

Ain Shams University, May 1991 “Duration of study Four years”

3- Objective:

To have: 1-Quality Assurance Manager, 2-Quality Control Manager (Microbiology), 3-Production Manager (Sterile both aseptic and terminal techniques, Oral liquids / Oral drops, Soft gelatin production areas & Dispensing), That allow me to utilize my experience, skills & capabilities to educate and coach others in Order to be consistent with established standards as well as applying continuous Improvement program (Cost effectiveness and process robustness).

4-Past Experiences:

Technical :

1) Review with direct reports (More than 70 employees) improvements in cost effectiveness, manufacturing processes and procedures.

2) Setting system for auditing program both Self inspection and internal auditing systems.

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3) Review with the direct reports of the concerned department new machine specifications and assure its compliance with the company requirements.

4) Manage warehouse control systems to monitor the performance of environmental control, raw material handling and identification and data control systems to assure that FIFO system is applied, raw materials are in the appropriate storing conditions, minimize the risk of cross contamination and stoke rupture.

5) Set the prospectus of new machinery and production lines to serve the update of a part or full production facility or building of a new one.

6) Effective participation of product launch, technical trial both placebo and product.

Documentation :

1) Revise the new issued Batch Records after being accepted by department direct reports and approve it.

2) Review and update General SOPs and making sure that all direct reports understand it and make sure it comply with each section activities.

3) Review the issuance of the required materials quantities needed for production accordingly to the production plan.

4) Verify that documentation system in-place and in-use complying with GMP, QMS, MOH, ISO and contractor standards.

Management :

1) Identify with the direct reports the training needs in each section, review the training plans and arrange it with HR department.

2) Manage systems such as deviations, supplier complaints, change control and periodic product trending in collaboration with quality department to fulfill its intended purpose.

3) Manage with subordinates the periodic shut down for maintenance schedule and malfunction in machines that have severe impact on the production plan implementation.

4) Review the performance of different production units and lines.

5) Introduce the expected performance from subordinates and represents possible pathways for each section to achieve expectations.

6) Co-operate with subordinates to introduce advanced Lean Manufacturing Systems including Six Sigma into production sections.

7) Manage an aggressive Production or analytical Safety Program and approve (S4S, Safety alert, ZAP reporting and closure & Living safety program).

8) Interview production or Quality section heads, supervisors and specialists.

9) Direct, coach, reward, and disciplines subordinates.

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10) Drive a customer complaint investigation and form investigation team lead by direct reports if required do possible corrective or preventive action(s) according to collected data.

11) Co-ordinate with direct reports to supply the planning and production sections with required data to set production monthly and 6 weeks plan.

12) Co-ordinate with subordinates setting improvements plan for current and future production process.

13) Represent the process validation and clean validation plans to subordinates, handle deviations in these plans, managing CAPAs effectively.

14) Managing risks in site both safety and quality through identification, evaluation and an effective mitigation plans.

15) Develop and implement quality management strategy and plans, including resource, Systems, timescales, financials, to support, contribute to, and integrate within The organization’s annual business plan and long term strategy. 16) Develop and maintain systems to establish standards relating to activities and products And measure performance against established standards.

17) Define and check “In process control / control devices for manufacturing & packaging processes”.

18) Managing Non-conforming, batches at risk and rejects. 19) Application of statistical methods and data analysis to monitor site performance.

5-Experiences (22 Years in both Quality and production of Multi-national pharmaceutical companies):

5.1- From April 2011 till now: Production Section Head leading Oral Syrup / Drops, dispensing and Soft Gelatin production areas and delegated as value stream leader to manage Production activities with very successful outputs. 5.2- From Jan.98 till Mar.2011: Quality Assurance Section Head & Delegated to handle OQ managerial responsibilities in GlaxoSmithKline Egypt effectively with very Successful outputs.

5.3- From June 95 to Dec.97: Microbiologist in “Minapharm Pharmaceutical Company” Located in 10 th Ramadan city. 5.4- From Jan.94 to May 95: Microbiologist in “Arab Drug Company - ADCO”.

6- Reporting line:

6.1- Now, I'm directly reported to value stream leader with very successful outputs And I’m supervising 70 employees in NL VS factory El Salam site. 6.2- Previously, I'm supervising activities of 11 employees in Quality assurance section within GSK El Salam site. 6.3-Lead initiatives through managing Cross-functional teams & brainstorming sessions to settle Quality / Safety standards , and enhance continuous improvement program.

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7-Training courses: 7.1- Technical training courses: - Attended intensive training program for “ISO 9001, ISO 14001 & ISO 18001”.

- Attended intensive training program for “Risk Management / Mitigation plan”. - Attended intensive training course for “Clean room technology” for manufacturing

Of pharmaceutical & medical products ( By Dr. H.H.Schicht-Switzerland expert ). - Attended intensive training course for “Principles & Application of calibration”. - Attend training program for “Validation of computerized system” by Paul Snook

(UK technical advisor) - Attended intensive training course for “Live Line Clearance“by Tom Duffy (U.K expert). - Attended intensive training program for “Green Belt - Six Sigma approach” by UK experts.

- Attended training course for " Hazard Analysis and Critical Control Point – HACCP & Failure Mode and Effect Analysis - FMEA risk management programs. - Attended Root cause analysis (RCA) training program - Attended L2 internal audit Qualification program. - Management of GMP Deviations (Given by UK expert – Mr. Brian Orrell)

7.2- Management training courses: - Attended training program for “Problem solving & Decision making skills”. - Attended training program for “Supervisory Skills” - Attended a training course for “Seven Habits of Highly Effective & leading People”.

- Attended a training course for “Time management skills”. - Attended a training course for “Effective project management”. - Attended a training course for “Motivation & Coaching for success”. - Attended a training course for “Effective communication skills”.

- Attended a training course for “Effective presentation skills”. -Attended a training course for "Reporting skills ". -Attended a training course for "Leadership & Quality leadership edge ".

8-Capabilities: Problem solver, Decision maker, Ability to handle multiple tasks simultaneously, Planned & Organized, Disciplined, Leads initiatives, Team & project leader, Competent (Achieve all targets overcoming all obstacles).

9- Language skills: Excellent command of English, both written and spoken.

10- Examples of my work:

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- Auditing - Risk mitigation - Investigations- Improve our productivity- Improve NRFT- URS for new project

Hoping that you will consider my application kindly, please accept my Great appreciation Best Regards Helmy Ismail