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South Africa

Stability Supervisor

Company Fresenius Kabi Manufacturing SA (Pty) Ltd
Reference # QC 1001
Published 30/11/2020
Contract Type Permanent
Salary Market Related
Location Port Elizabeth, Eastern Cape, South Africa
Introduction
To maintain the stability testing program of the laboratory database
To coordinate & perform the GLP/GMP Compliance functions of all the related activities in the ChemLab that provide a necessary Support function to the laboratory QMS.
Job Functions Chemistry, Physics and Biology,Data Analysis,Data Management,Health & Safety,Investigation & Compliance,Laboratory Work
Industries Fmcg (Fast Moving Consumer Goods Sector),Food & Beverages,Oil & Gas,Petrochemical,Pharmaceutical / Medical / Healthcare / Hygiene,Regulatory
Specification
•Coordinate and allocate the testing of all stability trials following the ongoing stability program
•Completion of OOS/OOT/OOE investigation
•Management of laboratory consumables required for stability analysis by liaising with the standard technician
•Manage the pulling, analysis and review of the stability samples as per the schedule for the stability program.
•LIMS experience would be an advantage
•Review calibration checks on designated equipment following calibration procedure
•Review logbooks for the usage of equipment standards and reagents
•Manage the initiation of stability samples with the Stability Pharmacist
•Perform analysis as and when deemed necessary on instruction from the Laboratory Manager or as part of investigation purposes
•Writes and reviews standard operating procedures for the chem lab
•From time to time perform additional tasks within the department, which are consistent with the grade, qualification and training of the incumbent.
•Log and complete CC, CAPA, RA's, RCA as required
•Manage the training requirements for the team and timeously communicate them to the Lab trainer
•Ensure external and internal audit closures are completed timeously and in line with current regulations
Requirements
Minimum qualification, BSc or NTD (Analytical Chemistry)

3-6 years would be ideal
Previous pharmaceutical experience would be an advantage
Previous management/Leadership experience will be a definite advantage
Job Closing Date 01/12/2020
   
   
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Last Updated: 30-7-2020 [20.07.03.04]
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