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Omar ali Shehata

GMP Compliance

Agami, Alexandria, Egypt

Work Experience

  • Quality Assurance Compliance SupervisorFull Time

    Al Andalous for pharmaceutical industry

    Aug 2024 - Present -10 months

    Egypt , Giza

    • Job Details:Attached CV
  • GMP Compliance SupervisorFull Time

    Zeta Pharma

    Sep 2022 - Present -2 yrs, 9 months

    Egypt , Monufya

    • Job Details:Adherence for compliance Integrated Quality Policy and compliance to GMP guides. Review facility SOP according to the cGMP guidelines Maintain and assure quality system. Checks and follow GMP standards and implementation in the plant. Prepare, review, classify, investigate and follow CAPA issuance and completion for Deviation Prepare and issue Quality Risk Management Reports, follow effectiveness and CAPA if applicable. Prepare, review, classify and follow Change Control. Follow Product Complaints and evaluate, investigate, response to customer and follow CAPA. Follow Product Recall cycle and Mock-Up recall annually Responsible for prepare and issue internal audit plan, and department notification. Responsible for implementation of internal auditing program and all relevant activities (Classify point of non-conformity, follow CAPA, …. etc.). Deals with external audits and follow up on implementation of corrective/preventive actions’ plans. Follow Quality Management System requirement and updates. Follow Handling of Returned Drug Products and assure complying with the SOPs. Care about EHS program related to his responsibilities. Prepare quality plans for any changes in Zeta pre-assessed system/activity. Provide employee training on compliance related topics, policies, or procedures. Adherence to safety and environmental conditions. Ensure operators following for the work safe conditions in QA department. Responsible to execute any responsibility as and when assigned by QA Manager. Provide periodical reports with appropriate analysis regarding all compliance
  • Quality Assurance specialistFull Time

    European Egyptian Pharmaceutical Industries (eepi)

    Jul 2017 - Sep 2022 -5 yrs, 2 months

    Egypt , Alexandria

    • Job Details:Daily supervision on production units and writing daily reports. Checks hygiene & GMP standards in the planet. Batch & Dis-batch system. Follow the process of receiving and weighing the raw materials and cleaning of area and equipment according to SOP. Prepares, Reviews and updates (SOP) for related plants Non Conformity Reports (NCR) & Deviation follow up and investigation. Customer complains follow up and investigation. Corrective and Preventive Actions (CAPA) follow up. Assure compliance with GMP & GDP around the facility. Personal Follow up. Attendance of execution committee for Raw Materials, Packaging Materials, Finished Products and Chemicals. Calibration and maintenance follow up for all equipment's and balances. Vendor and service provider Qualification & Evaluation Participation in Internal Audits. Participation in Vendor Audits.
  • Chemist of water treatmentFull Time

    Falcon Egypt for water treatment system

    Jan 2017 - May 2017 -4 months

    Egypt , Alexandria

    • Job Details:Water treatment of boilar & cooling tower , and RO Systems
  • Education

    • Bachelor's Degree in Chemistry in Chemistry

      Alexandria University (ALEXU)

      Jan 2010 - Jan 2014 - 4 yr

    • High School - Thanaweya Amma

      مدرسة الوقن الثانوية بنين

      Jan 2010 

    Achievements

    • Attended and lead EDA inspection on Zeta Company, Getting GMP certificate Sep 2022. • Attended and lead Libya inspection on Zeta Company, Getting GMP certificate Dec 2022. • Attended and lead Sudan inspection on Zeta Company, Getting GMP certificate Jan 2023. • Attended and lead Congo inspection on Zeta Company, Getting GMP certificate Dec 2023. • Attended and lead ISO (IMS) inspection on Zeta Company, Getting ISO certificate Dec 2023. • Attended and lead ISO 50001:2018 inspection on Zeta Company, Getting ISO certificate Dec 2023. • Attended and lead ISO 27001&28000:2022 inspection on Zeta Company, Getting ISO certificate Jan 2024. • Attended and lead EU-GMP assessment inspection on Zeta Pharma Company in Mars 2024.

    Skills

    • deviation
    • Incident Investigation
    • Quality Assurance
    • Audit
    • GMP
    • CAPA
    • Risk Management
    • QA
    • Compliance
    • Microsoft Excel
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    Languages

    • Arabic

      Fluent
    • English

      Fluent

    Training & Certifications

    • ISO 27001

      BF·2024
    • ISO 28000

      BF·2024
    • ISO 50001

      BF·2023
    • ISO 9001

      BF·2023
    • ISO 45001

      BF·2023
    • ISO 14001

      BF·2023
    • • Self-learning (ONLINE) on Quality Risk management / HVAC System / Auditing / Deviations, Root Cause Analysis (RCA) Tools and Corrective and Preventive Action (CAPA) - Sequence flow for handling of any non-conformance in the GMP environment (USP)

      USP·2021
    • Water and Wastewater Treatment

      نقابة المهن العلمية·2017
    • Water and Wastewater Treatment Engineering: Physicochemical Technology

      (Edx.com) PH.D/Xia Huang (Not-certified)·2016
    • How to learn English language

      (Alison.com)(Not-certified)·2015
    • First aid

      (EdX.com) (Not-certified)·2015
    • English Modli Stream – Level 7

      معهد اللغات - المنطقة الشمالية العسكرية·2015
    • OSHA

      HTG·2014
    • Training course in Pharco Pharmaceutical Company

      Pharco Pharmaceutical Company·2013
    • Training course "Pharmacologic"

      نقابة المهن العلمية·2013
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