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Lab Quality Reviewer LQR

Fresenius Kabi
Gqeberha, Oos-Kaap
Full time
1 week ago
Responsible for the review of analytical data for the disposition of data for Finished Product, Stability, Water, Raw materials, Components and intermediate products.
  • Coordinate review of chemical testing (Finished products, Stability, raw materials, components, water and intermediates), liaising with the Laboratory Manager, to ensure release as per agreed timelines.
  • Coordinate review of LIMS Data (Finished products, Stability, raw materials, components, water and intermediates), liaising with the Laboratory Manager, to ensure release as per agreed timelines.
  • Coordinate with Finished Product, Stability & Raw Material Supervisors) to draft priority list for review as required.
  • Check and review of raw data report sheets, release finish products, Stability, raw materials and intermediates.
  • Assist with training of laboratory staff if and when required.
  • Ensure Good Laboratory Practice & GDP is followed at all times
  • Assist with writing and review of laboratory standard operating procedures if and when required.
  • Assist with investigation of any OOS results generated within the laboratory, including review of raw data
  • Assist if and when required with Completion of OOS investigations in Kabitrack within the agreed timelines. (IIA = 3 days, Investigation 30 day and extension if required before 30days)

From time to time perform additional tasks within the department, which are consistent with the grade, qualification and training of the incumbent

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