القائمة الرئيسية

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Quality Control Specialist-Microbiology At Sanofi |Pharmacy, or Science Vacancy

 Quality Control Specialist-Microbiology At Sanofi |Pharmacy, or Science Vacancy 

Quality Control Specialist-Microbiology At Sanofi |Pharmacy, or Science Vacancy


Cairo


JOB PURPOSE:                                


This position is responsible to execute the approved method of analysis for:


Sterile products, products non-required being sterile, microbiological assay of antibiotics, environmental monitoring of sterile & non-sterile areas, testing of insoluble particulate matter in Injectable products and identification of micro-organisms. Also, it is responsible to participate and to execute all activities necessary for validation of sterile and non-sterile areas.

KEY RESPONSIBILITIES AND DUTIES:


Performs necessary microbiological testing, issues certificates of analysis required and ensures that all obtained results are within the specified approved limit, using valid method of analysis.

Supervises sampling procedures and analyses all assigned products and ensures that all necessary testing is carried out following the approved written instructions.

Performs daily/weekly/monthly the environmental monitoring of clean and sterile area. (Water, air, personnel etc.).

 Performs microbiological assay for antibiotic products. (Each Batch).

 Performs sterility, particulate and LAL tests for sterile products. (Each Batch).

Performs microbial count for product non-required being sterile following the local approved SOP.

Identification of microorganisms following the approved SOP.

 Performs Environmental Zoning and monitoring for production areas regarding both viable and non-viable parameters.

 Performs testing of insoluble particulate matter in Injectable Products.

Participates and executes process validation periodically of sterile filling area, as stated in the approved local validation protocol.

Immediate reporting of out of specification test results or batch deviation reports whenever needed to the Chemical lab head and the Q.C manager.

Education:


Bachelor Degree in Pharmacy, or Science

Related Experience:


3 - 5  years experience in related positions, preferably in multinational company.


Special Knowledge/Skills:


command of English Language

Good computer skills

Familiar with new instrumental analysis techniques

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