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Summary Profile
Hassan Sobhi Hassan Hussein
Contact No.: 01013664263
Address: Elsalam city - Cairo
E-mail: Hassansobhi@rocketmail.com.
Personal Data
Date of Birth: November 05, 1986.
Marital Status: Married.
Military Status: Exempted.
Career Objective
To achieve professional excellence in the quality control field by motivating a team dynamically that
works towards the growth of the organization and individuals.
Relevant Experience
Experience (Present):
Job title: Quality Control assistant manager.
Company Name: Averroes Pharma for pharmaceutical industries.
Date of employment: 01 January 2016 till current.
Job Profile (Present):
 Manage and monitor staff responsible for QC department and projects focused on support of
Quality Control.
 Manage internal and external quality inspections and audits including (reporting and response
to observations).
Summary Profile:
 Approve specifications, sampling instructions, test methods and other quality control
procedures and records.
 Check the maintenance of department, premises and equipment.
 Check the calibration of department equipment.
 Ensure that all appropriate validations and qualification are done.
 Ensure that the required initial and continues training of QC department personnel are carried
out and adapted according to need.
 Ensure the monitoring and control of the manufacturing environment.
 Contribute in process and cleaning validation.
 Ensure that the analytical method validation studies are done according to the predefined plan.
Contribute in approval and monitoring the contract manufacturers.
 Manage the retention of the QC record.
 Monitor the compliance with the requirements of cGMP and GLP.
 Monitor the execution of the product stability programs.
 Administrative and management work of the department.
 Work planning and workload management.
 Participate in the investigation of complaints related to the quality of the materials and product.
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Experience (Previous):
Job title: Quality Control Section head
Company Name: Averroes Pharma for pharmaceutical industries.
Date of employment: 01 May 2015 till 01 January 2016.
Job profile (Previous):
 Prepare the SOP related to QC process, operation and Maintenance.
 Check the OOS of analysis or test for raw materials, Packaging and Finished product.
 Follow the implementation of the corrective / preventive action taken through the external or
Internal audit and reporting the final action to Quality manager.
 Follow the implementation of calibration plan in QC Department.
 Check the validity of the chemicals regents in QC Lab.
 Check the analytical results for raw Materials, Packaging Mat. And finished products.
 Training or follow up the training of QC analysts.
 Prepare the working stander and the specification.
 Check the documentation, records, and Log books of the analysts in QC Lab.
 Determination the quality parameters for primary or secondary Packaging materials which
suitable with products.
 Suggestions which impact in the improvement of QC Process.
Experience (Previous):
Job title: Microbiology Section head
Company Name: Averroes Pharma for pharmaceutical industries.
Date of employment: 01 March 2011 till 01 May 2015.
Job profile (Previous):
 Develop and manage a competency based training program for all microbiology lab staff and
provide coaching and mentoring for staff's personal and professional development.
 Ensure that the validation and calibration schedule are fulfilled.
 Ensure the controlling and monitoring of the microbiological contamination.
 Ensure the quality and safety issues of the process in the lab.
 Establish and Update the validation protocols and SOPs.
 Give the technical support.
 Member in the internal team audit.
 Member in the problem solving team of the company.
 Member of Risk management team.
 Responsible for the contact with other department and external vendors.
 Responsible for the risk assessment, CAPA, OOS, OOT.
 Supervision and evaluation of the lab. members.
 Training of Lab members.
 Check the log books, log sheet, content and order of the lab. , and certificates.
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Experience (Previous):
Job title: Microbiology supervisor.
Company Name: ADWIA
Date of employment: 01 June 2010 till 01 March 2011.
Job profile (Previous):
 Supervision of all process carried out in microbiology lab.
 Supervision of media fill.
 System validation.
 Qualification of system and equipment & Qualification stage (DQ, IQ, and OQ, PQ).
 Follow the implementation of the corrective / preventive action taken through the external or
Internal audit and reporting the final action to Microbiology section head.
Experience (Previous):
Job title: Microbiology Analyst.
Company Name: ADWIA
Date of employment: 01 January 2009 till 01 March 2011.
Job profile (Previous):
 Environmental monitoring test.
 Media fill.
 Sterility test for sterile products & raw materials.
 LAL test (Endotoxin test) for pyrogen free materials & products.
 Microbial limit test for raw materials &finished products.
 Biological assay test for antibiotics.
 Maintenance of standard strains.
 Validation of all tests mentioned above.
 Microbiological analysis of city water, purified water & water for injection.
 Validation of the shelf life of disinfectants used in sterile areas.
 Count of microorganisms.
 Confirmation of LAL sensitivity.
 Internal audit and reporting the final action to Microbiology section head.
Experience (Previous):
Job title: Quality control & R&D specialist .
Company Name: Vanchem for chemical industries and investment.
Date of employment: 01 July 2008 till 01 January 2009.
Validation and Qualifications:
Ensuring Compliance with cGMP and industry standards regarding the qualification and validation:
 Cleaning Validation.
 Facility Qualifications.
 Equipment/Instrument (Installation, operational and performance) qualification.
 Water system validation.
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 Media fill.
Educational Qualifications:
Bachelor of Science (Chemistry and Microbiology), Ain Shams University, May 2008
Grade: Excellent.
Post-Graduation Studies:
Studying master degree of microbiology in Ain Shams University, Biotechnology field of search.
Training:
Averroes Pharma:
 GMP& Quality Assurance training course under supervision of (MATC).
 GMP training course under supervision of (EQE).
 ISO 14001, 9001, 18001 and internal auditing (Averroes pharma).
 Course in ISO 14001 2 / 2012 by Engineering & Quality Experts (EQE).
 Course in OSHAS 18001 Certificate at 2 / 2012by Engineering & Quality Experts
(EQE).
 Course in Internal Audit at 2010 Certificate by Engineering & Quality Experts (EQE).
ADWIA:
 Internal course in People style at work
 Internal course in Course GMP
 Pharmaceutical and Biopharmaceutical Production, Quality and Control.
 Good Laboratory Practice (GLP) training course "as awareness”.
 Good Manufacturing Practice (GMP) 18001 training course "as awareness".
Training in GCWC Including:
Atomic absorption.
Spectrophotometer.
I.C.P (Inductively coupled plasma).
G.C (Gas Chromatography).
HPLC (High performance liquid chromatography).
GC/MS (Gas chromatography/Mass spectra).
TOC (Total organic carbon).
TOX (Total organic halogens).
THM (Trihalo methane).
Skills:
Language: English very good (Speaking, Listening, reading and writing).
Computer: Operating system windows 8, office package and internet.
Soft skills: Leadership, Communication and Team work.

CV-Hassan Sobhi

  • 1.
    P a ge 1 | 4 Summary Profile Hassan Sobhi Hassan Hussein Contact No.: 01013664263 Address: Elsalam city - Cairo E-mail: Hassansobhi@rocketmail.com. Personal Data Date of Birth: November 05, 1986. Marital Status: Married. Military Status: Exempted. Career Objective To achieve professional excellence in the quality control field by motivating a team dynamically that works towards the growth of the organization and individuals. Relevant Experience Experience (Present): Job title: Quality Control assistant manager. Company Name: Averroes Pharma for pharmaceutical industries. Date of employment: 01 January 2016 till current. Job Profile (Present):  Manage and monitor staff responsible for QC department and projects focused on support of Quality Control.  Manage internal and external quality inspections and audits including (reporting and response to observations). Summary Profile:  Approve specifications, sampling instructions, test methods and other quality control procedures and records.  Check the maintenance of department, premises and equipment.  Check the calibration of department equipment.  Ensure that all appropriate validations and qualification are done.  Ensure that the required initial and continues training of QC department personnel are carried out and adapted according to need.  Ensure the monitoring and control of the manufacturing environment.  Contribute in process and cleaning validation.  Ensure that the analytical method validation studies are done according to the predefined plan. Contribute in approval and monitoring the contract manufacturers.  Manage the retention of the QC record.  Monitor the compliance with the requirements of cGMP and GLP.  Monitor the execution of the product stability programs.  Administrative and management work of the department.  Work planning and workload management.  Participate in the investigation of complaints related to the quality of the materials and product.
  • 2.
    P a ge 2 | 4 Experience (Previous): Job title: Quality Control Section head Company Name: Averroes Pharma for pharmaceutical industries. Date of employment: 01 May 2015 till 01 January 2016. Job profile (Previous):  Prepare the SOP related to QC process, operation and Maintenance.  Check the OOS of analysis or test for raw materials, Packaging and Finished product.  Follow the implementation of the corrective / preventive action taken through the external or Internal audit and reporting the final action to Quality manager.  Follow the implementation of calibration plan in QC Department.  Check the validity of the chemicals regents in QC Lab.  Check the analytical results for raw Materials, Packaging Mat. And finished products.  Training or follow up the training of QC analysts.  Prepare the working stander and the specification.  Check the documentation, records, and Log books of the analysts in QC Lab.  Determination the quality parameters for primary or secondary Packaging materials which suitable with products.  Suggestions which impact in the improvement of QC Process. Experience (Previous): Job title: Microbiology Section head Company Name: Averroes Pharma for pharmaceutical industries. Date of employment: 01 March 2011 till 01 May 2015. Job profile (Previous):  Develop and manage a competency based training program for all microbiology lab staff and provide coaching and mentoring for staff's personal and professional development.  Ensure that the validation and calibration schedule are fulfilled.  Ensure the controlling and monitoring of the microbiological contamination.  Ensure the quality and safety issues of the process in the lab.  Establish and Update the validation protocols and SOPs.  Give the technical support.  Member in the internal team audit.  Member in the problem solving team of the company.  Member of Risk management team.  Responsible for the contact with other department and external vendors.  Responsible for the risk assessment, CAPA, OOS, OOT.  Supervision and evaluation of the lab. members.  Training of Lab members.  Check the log books, log sheet, content and order of the lab. , and certificates.
  • 3.
    P a ge 3 | 4 Experience (Previous): Job title: Microbiology supervisor. Company Name: ADWIA Date of employment: 01 June 2010 till 01 March 2011. Job profile (Previous):  Supervision of all process carried out in microbiology lab.  Supervision of media fill.  System validation.  Qualification of system and equipment & Qualification stage (DQ, IQ, and OQ, PQ).  Follow the implementation of the corrective / preventive action taken through the external or Internal audit and reporting the final action to Microbiology section head. Experience (Previous): Job title: Microbiology Analyst. Company Name: ADWIA Date of employment: 01 January 2009 till 01 March 2011. Job profile (Previous):  Environmental monitoring test.  Media fill.  Sterility test for sterile products & raw materials.  LAL test (Endotoxin test) for pyrogen free materials & products.  Microbial limit test for raw materials &finished products.  Biological assay test for antibiotics.  Maintenance of standard strains.  Validation of all tests mentioned above.  Microbiological analysis of city water, purified water & water for injection.  Validation of the shelf life of disinfectants used in sterile areas.  Count of microorganisms.  Confirmation of LAL sensitivity.  Internal audit and reporting the final action to Microbiology section head. Experience (Previous): Job title: Quality control & R&D specialist . Company Name: Vanchem for chemical industries and investment. Date of employment: 01 July 2008 till 01 January 2009. Validation and Qualifications: Ensuring Compliance with cGMP and industry standards regarding the qualification and validation:  Cleaning Validation.  Facility Qualifications.  Equipment/Instrument (Installation, operational and performance) qualification.  Water system validation.
  • 4.
    P a ge 4 | 4  Media fill. Educational Qualifications: Bachelor of Science (Chemistry and Microbiology), Ain Shams University, May 2008 Grade: Excellent. Post-Graduation Studies: Studying master degree of microbiology in Ain Shams University, Biotechnology field of search. Training: Averroes Pharma:  GMP& Quality Assurance training course under supervision of (MATC).  GMP training course under supervision of (EQE).  ISO 14001, 9001, 18001 and internal auditing (Averroes pharma).  Course in ISO 14001 2 / 2012 by Engineering & Quality Experts (EQE).  Course in OSHAS 18001 Certificate at 2 / 2012by Engineering & Quality Experts (EQE).  Course in Internal Audit at 2010 Certificate by Engineering & Quality Experts (EQE). ADWIA:  Internal course in People style at work  Internal course in Course GMP  Pharmaceutical and Biopharmaceutical Production, Quality and Control.  Good Laboratory Practice (GLP) training course "as awareness”.  Good Manufacturing Practice (GMP) 18001 training course "as awareness". Training in GCWC Including: Atomic absorption. Spectrophotometer. I.C.P (Inductively coupled plasma). G.C (Gas Chromatography). HPLC (High performance liquid chromatography). GC/MS (Gas chromatography/Mass spectra). TOC (Total organic carbon). TOX (Total organic halogens). THM (Trihalo methane). Skills: Language: English very good (Speaking, Listening, reading and writing). Computer: Operating system windows 8, office package and internet. Soft skills: Leadership, Communication and Team work.