Spécialiste réviseur de données micro lab

PharmascienceCandiac, QC, CA

30+ days ago

Job type

Full-time

Job description

Under minimum supervision, performing detailed and timely review of microbiology raw data and results generated during testing of raw material, stability, finished and semi-finished products, and ensure that all produced data and results are in accordance with methods, specifications, SOP's and Good Laboratory Practices.

Responsabilities & Duties

Verifying all microbiology laboratory documents such as laboratory notebooks, laboratory result sheets and instruments;
Review of LIMS batches and testing, and review of laboratory results for samples out of LIMS.
Verifying all laboratory results ensuring accuracy, integrity and traceability of supporting raw data are produced in accordance with GLP, testing method and standard operating
Assist supervisor and investigator during investigations of OOS results and consult the department manager regarding omission, deviation, incomplete results and other irregularities.
Participate at the cross-verification of results generated by analysts
Write trend reportsPerform any other related tasks

Skill, knowledge & abilities

Good knowledge of microbiology analyzes in the pharmaceutical industry (sterile and non-sterile);

Knowledge of GMPs;

Good knowledge of Microsoft office;

Good level of French and English, both spoken and written;

Attention to detail and a job well done;

Good teamwork skills;

Good priority management;

Good knowledge of computer systems (ex. LIMS)

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Lab • Candiac, QC, CA