Seeking a challenging position in Q.A management field utilizing my qualifications, offering
excellent work efficiency ,enriching my experience ,creatively ,translating ideas and maintain continuous improvement through work flow.
! Diplome of T.Q.M (Total Quality Management) Arab Academy for Science and Technology Excellent - G.P.A 3.72 ! Diplome of Project Management Cambridge Training College INTERNATIONAL CERTIFICATE NO: 25032010220 ! Diplome of Human Resources Management Cambridge Training College INTERNATIONAL CERTIFICATE NO: 25032010221 ! B.Sc. in pharmaceutical science Tanta University, Faculty of Pharmacy, Egypt Graduation grade/year: Good/2007 Ahmad Gamal Azzam- Cell: +20-100 232 0381 +20-1129611122 E-mail: dr.3azzam@yahoo.com
EDUCATION & QUALIFICATIONS
OBJECTIVE PART A Page 2 of 7
Arabic : Mother tongue English : Very good command of spoken and written
1. SCM - Supply Chain Management Course 2014 2. Crisis and risk management 2013 3. Root Cause / Corrective Action Course 2013 4. Calibration Course In The Field Of Temp ,Pressure, Weights & Length 2013 5. Quality/Environmental Management Systems Auditing 19011:2002 2013 6. GLP 40 CFR Part 160 2013 7. EMA Sterile Manufacturing 2013 8. GMP Of Sterile Manufacturing Eudralex 2012 9. WHO cGMP Regulations 2012 10. Leadership , Motivation & Team Building 2012 11. Level 5 English Course 2011 12. FDA cGMP Course - 21 CFR Part 210&211 2010 13. Fire Fighting 2009 14. Train Of The Trainer Certificate 2008 15. Sops Writing Course 2008 16. Organizational Behavior 2008 17. Time Management 2007 18. First Aid 2007 19. NLP (Neuro-Linguistic-Programming) 2005 20. Windows Xp & Ms Office 2003 2004
CERTIFICATES & COURSES Languages Page 3 of 7
Employer Title Time period ATOS-PHARMA QA General Manager Nov 2013- present Three Plants/factories; 1-Pharma 2- Extraction (API) 3-Herbs Certified : ISO 9001, 17025 , 14001 , 18001 Quality agreement with SANOFI for 12 products manufacturing at Atos ( in progress ) Employer Title Time period EUP-Eimc united Head of Compliance (Sterile) Oct 2012-Oct 2013 EMA approved for sterile oncology manufacturing Two sterile areas ( oncology {European} and non oncology products) solid manufacturing area and syrup manufacturing area. Employer Title Time period SIMCO Medical Products QA manager Mar 2012-Oct 2012 Building and preparing QA system from the scratch to be certified as a cephalosporin Products manufacturer. (Company was liquidated) Employer Title Time period ATCOPharma QA Section Head (act as QA manager) Oct 2010-Mar 2012 Start Up From The Scratch QMS ,HVAC , water station IQ,OQ ,PQ Other Qualifications , Validation (process & cleaning ) - Products Registration & transfer follow up Employer Title Time period SIGMA ! Q.A I.P.C sr. officer ! Production Specialist Aug 2007- Oct 2010 Q.A sr. officer: Solids Department (Preparation, compression, caps. & sachets filling, coating, blistering & packaging) Production Pharmacist: in preparation and packaging of syrups , semi-solids & softgelatin.
Instructor / Trainer Technical Instructor: at Sigma ,Simco , Eimc & Atos companies Fields : cGMP ,Cleaning validation , Documentation ,Quality management & sterile manufacturing Freelance Trainer: conducting sessions in leadership, human development and soft skills, handling most of the training activities such as designing courses, preparing material, presentations,& leading different training methodologies (Lecturing - Role Plays - Case Studies - Brainstorming - Games - Individual/Team Exercises). Employment History Page 4 of 7
Highly Dynamic ,innovative with excellent Leadership skills & Ability to work under pressure and for long time alone, never give up, with proven communication & negotiation skills at all managerial levels, eager to learn supported by broad & professional knowledge, background & capabilities.
Date of birth: 23/7/1981 Marital status: married Military status : exempted Residency : 10 th of Ramadan district 25 building No.42/3 flat 5 Other residency : 6 th October district 8 th building No.99 flat 404
Problem solving Decision making Psychology, Psychotherapy & Human behavioral study
Advanced user of windows XP ,7 and their applications Advanced user of internet and networks Very good user of Microsoft office Good user of MS-project Solid back ground about graphics & flash making apps; (photoshop & poser 4 ) Basic knowledge about programming, cracking & systems hacking.
Passing CMQ/OE exam ( at 3/2015 )
! Dr.Hisham Kamel Plant general manager Atospharma 01280555751 ! Dr.Hussain El Dars-Technical director- Sigma 01223338594 ! Dr.Omyma Noreddin- QA manager-Sigma 01222474120 ! Dr.Hammam Habshout Plant manager at Pharma-med 01120044887 ! Dr.Foad Mohyeddin- vise production manager -Sigma 01008001062 ! Mr.Ebrahim Abdallah- GM of CPAT-institute (career planning & training) 01004476667 Personal Profile IT SKILLS REFERENCES SELF STUDY GOALS Page 5 of 7
Quality agreement and manufacturing / supply agreement for 12 product in Atos -80% achieved in 6 monthes in all aspects of GMP to comply with Sanofi QMS (as a restart up)
1. Ensure timely completion of routine QA procedures, Manufacturing, Quality Control, and packaging,in process testing checks, sampling, warehousing and other agreed upon duties. 2. Manages inspections of raw materials, materials in process, and finished products. 3. Ensure implementing GMP Regulation and ISO 9001, ISO 14001, 18001 AND ISO 17025 Standards 4. Follow up with production processes to ensure quality standard. 5. Plan & perform quality audits, investigate root cause and evaluate required corrective actions 6. Ensure all phases of Manufacturing, comply with relevant SOPs, GMP principles & safety guidelines. 7. Planning & conducting preventive maintenance plans & Protocol for manufacturing process & analytical methods in addition to cleaning methods validation 8. Auditing the analytical laboratory for compliance with GLP and other applicable regulations. 9. Preparing, evaluating & updating Corrective & Preventive actions program. 10. Preparing & supervising deviations & investigation reports 11. Implementing Change Control System 12. Supervise Writing, reviewing, and distribution of SOPs 13. Batch records review , finished product release. & MOH inspection visits management 14. Manages & develops validation policies, VMP and procedures 15. Oversees the required validation activities & Qualification of systems and equipment (HVAC,Water station) & Calibration Master Plan 16. Manages VALIDATION OF SYSTEMS (equipment, utilities, facilities, product manufacturing processes, cleaning procedures)
Areas of work according to EMEA regulations & Eudralex guideline: 1. Leading & executing Self inspection-Internal audit program. 2. Annual product review program. 3. CAPA system. 4. Managing & facilitating the MOH routine visits 5. Log-sheet / batch record review 6. Contribute to the resolution of GMP issues within the organization through identification of problem areas and training of relevant personnel. 7. Trend analysis of viable environmental monitoring (Air & Water). 8. Trend analysis of non-viable environmental monitoring (Air & Water). Job Activities At Eimc United Sanofi - Atos project Work Achievements & Activities QA manager job description ATOS PART B Page 6 of 7
9. Monitoring daily activities & deviations (if any) on the previously mentioned areas. 10. Monitoring and follow up of deviations ,lab investigations ,OOSes ,alert notices & change control system. 11. Conduct training (on/off job training) in several working areas to all employees 12. Supervising media fill process 13. Supervising Validation & routine qualification activities
1. Design and qualification of water treatment plant. Equipments used, layout, water flow, DQ, IQ, OQ & PQ. 2. Design and qualification of production area, designing (rearranging) the layout, zoning ,! P , personal & material flow and room data sheet 3. Design warehouses (raw & finished) layout ,sections and work flow
1. Ensure timely completion of routine QA procedures, Manufacturing , Quality Control, and packaging ,in process testing checks, sampling ,warehousing and other agreed upon duties. 2. Manages inspections of raw materials, materials in process, and finished products. 3. Ensure implementing GMP Regulation and ISO 9001 ,ISO 14001 and 18001 Standards 4. Follow up with production processes to ensure quality standard. 5. Plan & perform quality audits, investigate root cause and evaluate required corrective actions 6. Ensure that all phases of Manufacturing, comply with relevant SOPs, GMP principles and safety guidelines. 7. Planning & conducting preventive maintenance plans & Protocol for manufacturing process & analytical methods in addition to cleaning methods validation 8. Auditing the analytical laboratory for compliance with GMP and other applicable regulations. 9. Preparing & updating Corrective & Preventive actions program. 10. Implementing Change Control System 11. Supervise Writing, reviewing, and distribution of SOPs 12. Batch records review & finished product release.
1. Participated in building of the entire plant project as the QA head. Starting from DQ till having the license in 7/2011. 2. Built the Documentation system ,ISO and GMP documents from A to Z . - Quality policy, manual, procedures, relevant SOPs . - Designed all the forms ,Labels and templates of: Batch records. (SOPs). 3. Created the Quality Manual , Established & Detailed the whole QMS of the company. 4. Participated in the project of preparing the Site Master File as a team member. Start up of Atcopharma plant QA Manager Job Description At Simco Design & start up Experience At Simco: ! GMP and ISO relevant forms. ! Warehousing of raw materials
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5. Prepared two IPC labs one for the syrup and the other for solid department; benches ,instruments and tools. 6. Supervised the execution of IQ ,OQ , commissioning & PQ of HVAC system /relevant document review. 7. Supervised execution of IQ ,OQ&PQ of water station (3 phases) /relevant document review 8. Supervised the execution of IQ & OQ of capsule filling ,liquid preparation tanks & filling ,labeling , sachet filling and dosering machines. 9. Designed and established documentation and management system of raw materials warehouse starting from materials receiving passing by racks coding till housing & inventory 10. Working on process validation of dry mixing products (6 products) 11.Working on cleaning validation starting from Methods of Calculating Acceptance Criteria passing by Bracketing And Worst Case Rating & Amount of residue determination ending with cleaning Validation protocol 12.Executed thermal mapping for WH , cold store ,cool store & refrigirators 13. Batch records review & finished product release. 14.Control & maintenance of documentation system. 15. Recently responsible of the ISO 9001:2008 certificate project.
! Observe conditions on line and in-process area for compliance with the process method, for correct operation of procedures and for cleanliness and clearance of other components. ! Responsible for Sampling of bulk and finished products to obtain representative samples. ! Perform checking tests at random throughout processes for critical start-up tests and to check for correctness of printed materials. ! Review the executed manufacturing batch records for completeness, correctness, compliance of in-process control results with specification and reporting of unusual incidents. ! Ensure production materials meet defined quality standards prior to disposition. ! Responsible for tracking and trending of out-of-specification results, failure investigation, nonconformance, deviations, change controls and complaints. ! Monitors the environment of production and material disposition areas.
! Handled all activities of packaging area (syrups & semi-solids department that composed of about 150 workers with 5 lines and a printing unit. Created and implemented a Domestic HR system in the same area making new job descriptions and specifications with performance appraisal and daily evaluation models based on effective KPI's according to different roles and positions. Implementing special techniques: - Job rotation - Shadowing - Couching - On job training (specially GMP requirements) Yielding a vast & remarkable improvement in ;Workers culture toward quality GMP & system compliance Increasing in productivity by about 9%
Further info. ,Original Certificates, and Documents are available upon request Job Description In Q.A Department At Sigma Achievements In Production At Sigma
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