QUALITY ASSURANCE MANAGER
DIVISION OF CLINICAL PHARMACOLOGY
DEPARTMENT OF MEDICINE
FACULTY OF HEALTH SCIENCES
We invite applications from suitably qualified candidates for the post of Quality Assurance Manager.
The purpose of this position is to manage all quality assurance programs within the Division of the Clinical
Pharmacology laboratory, including adherence to all internationally applicable quality standards.
The successful candidate will have the following major responsibilities:
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Management of the Quality Assurance Division within the Pharmacology Laboratory.
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Responsibility of compliance of the Pharmacology laboratory with ISO 17025 criteria and maintenance of
accreditation of the laboratory with the South African National Accreditation System (SANAS)
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Management of all quality assurance systems in the AIDS Clinical Trial Group (ACTG)-associated NIH
International Pharmacology Specialty Laboratory (IPSL) within the Division of Clinical Pharmacology.
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Quality assurance of all assay validations by LC tandem mass spectrometry according to FDA and EMEA
guidelines
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Quality assurance of all clinical trial laboratory research data.
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Quality assurance of preclinical and in vitro data from the Pharmacology component of the UCT/MRC Drug
Discovery and Development Unit
Other
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specific responsibilities include:
Maintenance of the required documentation and archiving system,
Ongoing QA training of all staff working within the laboratory,
Routine internal audits on all data produced by the analytical laboratory
Management, storage and release of the data generated by the projects undertaken by the laboratory.
ACTG/NIH
o Setup, implementation and maintenance of the laboratory data management system (LDMS).
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Quality Assurance Management
o Developing, writing, implementing and maintaining the standard operating procedures required for the
routine and analytical laboratories within the Division.
Requirements

Postgraduate degree relevant to Pharmacology or equivalent qualification
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Five years experience as a quality assurance manager in a Pharmacology laboratory
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Experience with assay development and validation by LC tandem mass spectrometry
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Experience in data management
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Experience in the analysis of pharmacokinetic data will be an advantage.
The annual remuneration package, including benefits, is negotiable between R 344 130 and R 404 849.
Application process:
To apply, please e-mail the completed UCT Application form and all other relevant documentation as indicated on
the form, to Ms Melanie Falken, Staff Recruitment and Selection, University of Cape Town, Rondebosch, 7700.
E-mail: melanie.falken@uct.ac.za
Telephone: +27 21 6505764
Website: www.medicine.uct.ac.za
The application form can also be downloaded at http://web.uct.ac.za/depts/sapweb/forms/hr201.doc.
An application which does not comply with the above requirements will be regarded as incomplete. Only shortlisted
candidates will be contacted.
Reference number for this position:
SR179/11
Closing date for applications:
16 September 2011
UCT is committed to the pursuit of excellence, diversity and redress. Our Employment Equity Policy is available at
http://hr.uct.ac.za/policies/ee.php.
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