Quality Control Professional At Sanofi

Quality Control Professional - Microbiology (Contract end Feb. 2024)

Job Purpose:

It will mainly be responsible for the execution of the approved method of analysis for sterile products, products non-required being sterile, environmental monitoring of sterile & non-sterile areas.

In addition to testing of insoluble particulate matter for injectable products and the identification of micro-organisms. In addition to the participation and to execution all activities necessary for validation/qualification of sterile and non-sterile products/areas.

KEY RESPONSIBILITIES AND DUTIES:

Performs all necessary approved testing procedures of microbiological procedures for non-Cephalosporins materials & products, issues certificates of analysis required and to ensure that all obtained results are within the specified approved limit, using valid method of analysis.

Supervises sampling procedures and analysis for specified products & materials and ensures that all necessary testing is carried out following approved written instructions (each batch) of the assigned products.

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

Performs daily/weekly/monthly the environmental monitoring of sterile and non-sterile areas. (Water, air, personnel etc.).

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

Identification of microorganisms.

Performs Environmental 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.

Release of S.F. products.

Perform Stability testing.

Utilizes, calibrates, maintains the QC equipment in the micro Lab according to the local SOP.

Prepares relevant SOPs and follows up the update according to requirements.

Performs other related duties as assigned.

Makes sure that all activities carried on are complying with safety measurements.

Updates methods of analysis.

Others:

Perform other duties as assigned.

Respect of company’s values, code of ethics and social charter.

Respect of personal data protection charter.

Responsible for applying the HSE related requirements for the company in all related working procedures.

JOB-HOLDER’s ENTRY REQUIREMENTS:

Education:

Bachelor Degree in Pharmacy, or Science

Related Experience:

6 months - 3 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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