Stability Supervisor

Stability Supervisor

22 Nov
|
Fresenius Kabi Manufacturing SA (Pty) Ltd
|
KwaXhosa

22 Nov

Fresenius Kabi Manufacturing SA (Pty) Ltd

KwaXhosa

Company



Fresenius Kabi Manufacturing SA (Pty) Ltd





Reference #



QC 1001





Published



20/11/2020





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



04/12/2020

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