Analyste Physico-Chimique (Environement Sterile )

Job Scope

Analyzing of all product/material chemically and physically, by following standard operating procedures, to ensure compliance with the approved specifications, documenting the results in the specified forms, and sending them to the direct supervisor

Executive & Technical Duties

-   Receiving monthly programs and the daily business from the Supervisor and complying with the instructions, and work on analytical devices configuration and checking their   qualification and calibration set out before starting the analysis on them.

-   Conducting the necessary preparations of materials, chemicals, auxiliaries' reagents for analysis, tools, and chemical solutions in the specified periods.

-   Conducting physical and chemical analysis for Validation product samples and following standard operating procedures and complying with local SOPs.

-   Checking the obtained analysis results to ensure conformity with the defined specifications by comparing the results with the specifications' instructions and standards and doing the necessary calculations and writing the required reports.

-   Entering the analysis results on the specified systems and documenting all results within adopted analysis report and forms for each material and writing reports that demonstrate all analytical procedures and obtained results for each material and delivering them on time for the direct supervisor.

-   Sampling, Testing and reporting for Cleaning Validation

-   Validation of Analytical Method

-   Manage Validation Samples

-   Follow up Testing Status, sending analytical data of validation product to Quality assurance, Validation, production departments

-   Follow up Finished product till released by QC.

-   Follow up raw material purchase orders

-   Applying all the rules and practices of good manufacturing (GMP) and good laboratory practices (GLP) in the laboratory and while doing the analysis process.

-   Providing their ideas to improve work and reduce cost.

-   Responsible for neatness of the analytical lab and housekeeping.

-   Labeling of prepared solutions.

-   Conducting calibration of instruments.

-   Conducting reagent inventory, spare parts inventory.

-   Applying General System SOPs e.g. deviation management. Initiate a deviation report, initiate change control.

-   Operate and clean chemistry laboratory instruments in accordance with standard operating procedures.

-   Take part in training sessions scheduled by the annual training plan approved. Update training record.

-   Issuing and amending relative SOPs and STMs.

-   Archive all reports (analytical, calibration and out of specification) and obsolete documents.

-   Receiving reagents, columns, spares part following the relevant procedures.

-   Take decision as necessary.