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- 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
- 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)
Spécialiste réviseur de données micro lab - Candiac, Canada - Pharmascience
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
Skill, knowledge & abilities