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- 1. Hany Mohamed Gomaa Cairo, Egypt Mobile: 01005083539 01288408111 E-mail: hany_otsuka@yahoo.com hgomaa@marcyrl.com Personal Data: Date of Birth : 16/7/1976 Place of Birth : Egypt Marital Status : Married Military Serves : Exempted Career History Marcyrl Pharmaceutical Industries From 2-2011 till present position Senior Quality Assurance Manager & Management Representative From 1-2012 till now Responsibilities Management ,control and review of all related documents for the final release of Batch/Product. The Authorized person responsible for compliance with technical or regulatory requirements related to the quality of Finished Products Sets QA compliance objectives and ensuring that targets were achieved. Manage the implementation of cGMP to be strictly followed throughout the Manufacturing processes. Ensures that Quality is built into the Product. Verify And Follow Up Implementation Of GMP and New Quality Policy Requirements.
- 2. Manage and approve Change control system , Risk management by FMEA methodology Manage the preparation of Standard Operating Procedures related to various activities in the Factory. Manage all procedures related to Document Control. Application of six sigma procedures in specification setting. Manage the conduction of Technical Training to Staff. Manage the effective monitoring of Calibration & Preventive Maintenance of Equipment. Manage any unusual Incident through: Reporting Investigation Corrective / Preventive action. Internal Lead Auditor on all departments and Approve schedule for internal audit plan. Manage the performance of External audits on Suppliers. Manage the execution of Observation raised by External Audits on the Factory. Prepare and maintaining the Validation Master Plan for the validation activities for the facility, utility and equipment to ensure they are all adequately validated for c GMP projects. Manage the implementation of all Validation activities: Process Validation HVAC Validation- Cleaning Validation IQ / OQ / PQ Qualification of Equipment validation of tunnels- SIP Validation Validation Of Aseptic Process water station validation - sterilization validation in autoclaves - Computer System Validation. Manage the preparation and execution of validation protocols & validation reports .Review and approve the protocols and reports. Communicate With Planning Department To Identify The Priorities Of Production Processes. Ensuring compliance with national and international standards and regulations. Establishes the policies and procedures manual to the asset operations activities, and monitors their ongoing implementation and compliance.
- 3. Incorporates all changes upon their occurrence, and ensures clear communication of those changes to his direct report. Management of the documented Change control activities and follow up taking the appropriate measures for validation and approval. Responsible for ensuring the equipment, manufacturing and testing facilities and utilities are validated and any revalidation studies are performed with coordination with all concerned departments. Responsible for Carry out Product Recall In case it happens. Set procedures that ensure the correct handling of materials and documents. Manage and review non-conforming events including product recalls, customer complaints and internal non-conforming events& follow up execution of any recommendation & CAPA action plan. Manages subordinates and ensures their continuous technical improvement. Review & approve Standard Master Formulae of products. On ORACLE system. Approved all Bill of Materials. on ORACLE system. Marcyrl Pharmaceutical Industries position Quality Assurance Assistant Manager From Feb -2011 till Jan- 2012 Responsibilities Reported to Q.A Manager Set Up And Develop A GMP Validation Program Including Master Validation Plan, Protocols & Reporting System. Organize Validation Working Groups For Specific Validation And Qualification Protocol. Conduct& Lead The Internal and External Quality Audit Activity According To Marcyrl QMS Requirements. Communicate With Validation Team& QA Officer about The Required Validation Of New Product, Cleaning Validation, New Line M/C Validation& Projects.
- 4. Investigate And Highlight The GMP Deviations ,Critical Incidents And OOS That Could affect On The Quality Of The Product And Follow Up The Implementation Of Corrective & Preventive Actions. Review The KPIs ( Key Performance Indicators) Of QA Investigate The Significant That Need Rapid Action For Patient Safety Or Adulteration. Report Monthly To QA Manager About Batches At Risk. Issuing And Update All Related QA Functions Sops According To Updated. Update of Our Document According To New Issue of GMP. One of Team Which Participate In the External Audit Which Come To Marcyrl Co. And Follow Up The Required Corrective Action That Must Be Taken And Implemented. Define And Check IPC Tests For Intermediate Bulk Product And Finish Product As Well As Online Troubleshooting Of Processing And Packing Lines. Handling and Investigate Customer Complaints and Propose Preventive Actions. Assess The Products Quality Performance Annually Via (QA Annual product Review) And The Recommendations For The Product Quality Improvement. Effective Participating As QA Representative in New Line Upgrading Projects. Participating In Validation Team of New Product And Process Validation. Follow Up The Self Inspection Reports Audited By QA Officers The Possible Corrective Action With Engineering , Production Planning And Staff The Lead Auditor Holds the Over All Responsibility for Compiling and Ensuring. Execution the Level Two Site Quality Audit Program as Following. Setting Dates With Area To Be Audited Agreeing Audit Scope And Timetable With Area Liaise With Audit Conduct. Audit Preparation Lead Audit Introduction Meeting. Documentation of Observations.
- 5. Agree Responses With Management Team Audited Area. Write Audit Report. Discuss The Audit Finding With Quality Manager And Get His Authorization. Report Excusive Summary Of The Finding Observations To Quality Manager Receive and Evaluate Audited Responses Then Re- Discuses the Relevant Action with The Auditee If Is Not Satisfactory. Compile A Report Listing The Responses To The Audit Observations. Responses Including Corrective And Preventative Actions, Target Dates For Completion And Responsible Person For Each Observation For Follow Up The Progress.
- 6. Egypt Otsuka pharmaceutical co. From DEC. -2000 till FEB- 2011 U positionU Quality Assurance Section Head From DEC. 2007 till Feb. -2011 UResponsibilities Manage And /Or Co-Ordinate The Implementation Of Business Process Improvements At A Site In Support Of Business Targets. Setting And Review Of Documents Required For Validation Example Validation Master Plan , IQ ,OQ , And PQ Documentations. Responsible For Making (Simulation Process) Media Fills. Responsible For Making Validation Of S.I.P (By Thermal &Biological Indicator). Responsible For Validation Of Terminal Sterilization ( Cycle Time For Autoclaving And Found The Coldest Point In Autoclave & Approval Validation Cycle Reports. Responsible For Validation Of HVAC System( Validation Of HEPA Filter By Integrity Test Using DOP Method ,Measuring Of Air Velocity And Calculate No Of Air Change ,Measuring Of Particle Count ( Non-Viable ) ,Air Pattern By Smoke Test , Temp.,& Humidity Also Evaluation Of Clean Room Design At Rest& In Operation Lead the Team Who executes Cleaning Validation In Otsuka Pharmaceutical Co. Participate In Site Calibration Program Through Setting Critical Calibration List Of Instrumented Machines, Calibration Of IPC Instruments And Balances Experience In Working With Change Control System CCR To Manage Change Process Without Affecting Product Quality.
- 7. position Quality Auditing Departmental Head FEB - 2004 till DEC. -2007 Responsibilities The Lead Auditor Holds The Over All Responsibility For Compiling And Ensuring Execution The Level Two Site Quality Audit Program As Following. Setting dates with area to be audited Agreeing audit scope and timetable with area Liaise With Audit Conduct. Audit Preparation Lead Audit Introduction Meeting. Documentation Of Observations Agree Responses With Management Team Audited Area Write Audit Report Discuss The Audit Finding With Quality Compliance Manager And Get Report Excusive Summary Of The Finding Observations To Site Director & Quality Manager Receive And Evaluate Audited Responses Then Re- Discuses The Relevant Action With The Auditee If Is Not Satisfactory Compile A Report Listing The Responses To The Audit Observations. Responses Including Corrective And Preventative Actions ,Target Dates. For Completion and Responsible Person for Each observation For Follow ups the Progress. Finalize all NCR by follow up all CAPA.
- 8. Egypt Otsuka pharmaceutical co. position Quality Assurance supervisor Aug. - 2002 till FEB -2004 Egypt Otsuka Pharmaceutical Co. Position Quality Assurance Officer DEC - 2000 Till AUG -2002 Education From 1994-1998 (Ain -Shams University (Egypt)) Bachelor Of Science Major Chemistry Very Good Degree Training courses Courses for Six Sigma Black belt for more than 8 months which contains (Leadership, Statistical Process Control, Bench marking, Business performance measures, Financial measures, Time management for team, team decision making tools, Management and planning tools, Team performance evaluation, Voice of the customer, Measurements system, Basic statistics, Process capability, Failure mode & effects analysis, waste elimination, Cycle-Time Reduction, Kaizen and Kaizen Blitz, Risk analysis and Mitigation and Robust Design and Process) Certified internal auditor on Quality management system ISO 9001:2008, Certified For ISO 14001-2004 Auditor &Internal Environmental Auditing Courses In Basics To Advanced GMP In Medicinal Manufacture. Courses for Process validation, cleaning validation, process capability & annual product review GAMP 4 Awareness - PL Consultancy Computer Compliance and Validation
- 9. Courses In QA & Manufacturing procedures of various dosage forms. Workshop in Otsuka- Egypt about Quality Improvement& Problem Solving Root cause analysis techniques Human error prevention Human error root causes Human error measurement Quality and safety culture Effective Communication Skills. Training About behavior in sterile area ORACLE Education Courses Oracle Process Manufacturing : Production Management. Oracle Process Manufacturing : Process Operating Control. Oracle Process Manufacturing : System Setup. Oracle Process Manufacturing : Inventory Control. Oracle Process Manufacturing : Formula Management. Oracle Process Manufacturing : Production Management. Oracle Process Manufacturing : Production Management Quality Management System ISO 9001 : 2000 year 2002. Environmental management System ISO 14001 year 2002. Personal characters: skills and qualifications High Experience In Q.A Operations (cGMP & ISO Regulations ) High Experience In Pharmaceutical Validation Operations Concerning Process ,Product, And Utility Validation. High Degree Of Flexibility And Problem Solving Skills. Managerial characters ,Good leadership skills & Communication Skills. Hard Worker And Can Work Under Stress Negotiation Skills. Presentation Skills. Excellent Computer knowledge & Oracle Manufacturing Programs.
- 10. Very good command in both Arabic & English languages High Sense of responsibility Excellent research capabilities, high ability to learn, teach. Work with groups & independently. Work under stress & deadlines. High accuracy and sense of responsibility. Punctuality Plan oriented Good Teaching and instruction skills Commitment & dedication to the job duties Problem solving skills Do not know Elias BEST REGARDS Hany