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Validation Inspector - Pharmaceuticals

Egypt Otsuka

Posted on January 13, 2020

1 - 3 years Egypt - Egypt

Bachelor of Pharmacy(Pharmacy). Any Nationality

Opening 01

Job Description

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The position holder is responsible for Creation, and the execution of the proper framework that governs the qualification activities for the process validation activities and cleaning validation activities within the organization Quality Management System.
• Ensure fulfillment of the requirements of company global quality policies and the regulatory agencies both domestic MOH and the foreign within the scope of the company operations. He will work under a defined SOPs and policies that need to be fulfilled.
Responsible for execution, monitoring and reporting of the following
• All Classified areas Qualification
• Ampoule Machines SIP Validation
• Autoclave Validation
• Steam quality test Qualification
• Compressed Air Quality test Qualification
• Thermal Mapping Studies for warehouses
• Vacuum Chambers Qualification
• Light intensity Qualification
• Media fill aseptic simulation studies on Ampoule Machines
• Cleaning and Process Validation
• equipment qualification
• All Pass Boxes Qualification
• All AHUs reconciliation and Qualification in coordination with the engineering department
• Monitoring all external activities done by the outsourcing and archive reports
• Participate in SOPs creation and revising
• Prepare the Validation calendar Plan and index Annually, validation protocols and reports
• Any Other tasks within the scope of validation department duties assigned by validation supervisor
Responsible for Calibration, Monitoring, and reporting of the following
• temperature Sensors
• Calibration for all devices and cougar, sensors in all factory and QC lab
• Thermal mapping for the controlled room QC lab
• Conductivity Meters
• All Tablet section IPC lab devices (Disintegration, friability , hardness, and thickness)
• Thermo hygrometer calibration
• Participate in SOPs creation and revising
• Prepare the Calibration calendar Plan and index Annually
• Any Other tasks within the scope of calibration department duties assigned by validation supervisor
• Fulfill other related tasks as asked by management and as arising from the business.
job requirements
1 to 3 years
Not Specified at least
Manufacturing Pharmaceuticals


Other

Quality / Testing / QA / QC / Inspector

Desired Candidate Profile

Bachelor s degree in Pharmacy or scientific
• 1 3 years of experience in the field.
• Good command of English language and computer skills
• leadership skills.
• Teamwork skills.
• High communication skills and able to work in a team and able to interact with various priorities
• Active, organized and planner with high attention for details
• High observation skills

Keywords

Validation Inspector - Pharmaceuticals Manufacturing

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Egypt Otsuka

About this Company
Egypt Otsuka Pharmaceutical Co., S.A.E. is a subsidiary of the Global Pharmaceutical Company Otsuka, part of Otsuka Holdings of Japan. Otsuka Holdings has over 77 companies and listed in the Tokyo Stock Exchange.
Otsuka Pharmaceutical was established in Tokushima...
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Industry:
Manufacturing
Pharmaceuticals
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