JOB DESCRIPTION
HR191
POSITION DETAILS
Position Title
Status of Post (tick)
Job Grade
Quality Assurance Manager
New Post
11
Faculty (if applicable)
Health Sciences
Department
Medicine
Division (if applicable)
Clinical Pharmacology
Date of Compilation
February 2011
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FOR OFFICE USE
Job Title
Date of Grading
Grading Result
ORGANOGRAM
Head of Division
IPSL Reporting
Laboratory Director
PKRL Director
Quality Assurance
Manager
Quality Assurance
Administrator
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PURPOSE
The purpose of this position is to manage all quality assurance programs within the Division of Clinical
Pharmacology, including adherence to all internationally applicable quality standards. In particular, the
incumbent shall ensure compliance of the Pharmacology laboratory with ISO 17025 criteria and maintain
accreditation of the laboratory with the South African National Accreditation System (SANAS) and
manage all quality assurance systems in the AIDS Clinical Trial Group (ACTG)-associated NIH
International Pharmacology Specialty Laboratory (IPSL) within the Division of Clinical Pharmacology.
This includes:
 Maintenance of the required documentation and archiving system,
 Ongoing training of all staff working within the laboratory,
 Routine internal audits on all data produced by the analytical laboratory and
In addition to this, the position includes:
 Project management:
o Project management of the various projects undertaken by the Division of Clinical
Pharmacology Analytical Laboratory.
o Liaising with project investigators regarding the registration and progress of their projects
within the 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).
 Quality Assurance Management
o Management, supervision and training of various administrative staff members
responsible for the administration of the quality management system.
o Developing, writing, implementing and maintaining the standard operating procedure
required for the routine and analytical laboratories within the Division..
o Chemical Reference Standard management: Maintaining an up to date inventory, with
the required documentation for the analytical laboratories.
KEY PERFORMANCE AREAS (4-6)
Description
% time
1. Management of quality assurance process to ensure the implementation and
maintenance of all quality assurance systems, including procedures, methods,
policies, manuals and staff records according to IS0 17025 standards or higher in the
Pharmacology analytical laboratory. Management of quality assurance administrative
tasks performed by technical staff.
40
2. Ensure that all assays validated within the Division of Clinical Pharmacology
comply with the applicable international standards.
15
3. Data management as well as management of the archiving systems within the
Division.
5
4. Quality assurance of all laboratory data produced by the analytical laboratory.
25
5
10
5. Training of laboratory staff and students in Standard Operating Procedures
6. Effective management of analytical projects undertaken by the Division of Clinical
Pharmacology Analytical laboratory
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OUTCOMES
Maintenance of ISO 17025 accreditation with SANAS.
Accurate and up to date quality system documentation.
An efficient and effective quality control programme within the laboratory and maintenance of all
standards required for participating in NIH-funded clinical trials
A well controlled archiving system, providing records of all current and archived documentation, which is
easily accessible and well ordered.
A well trained cohort of staff, knowledgeable in the various aspects of quality control.
Efficient project management with quality data provided to clients on time.
An organized database of data generated by the analytical laboratory.
MINIMUM REQUIREMENTS
Minimum Qualifications
Postgraduate degree relevant to Pharmacology or equivalent
qualification
Minimum Experience
5 years of pharmacokinetic laboratory experience, Good laboratory
Practice training and ISO 17025 training.
Key Competencies
Knowledge of ISO 17025 systems as applied to a pharmacology
laboratory, including routine analysis as well as pharmacokinetic
work
Experience as an internal quality management systems auditor
Experience assay validation using HPLC and LCMSMS, as well as
the role of QA during a GLP study
Microsoft Office, basic databases
Statistical analytical packages, including graphing software and
pharmacokinetic analysis
AUTHORITY
PRINT NAME
Compiled by
Prof. P. Smith
Approved by
Professor Peter
Smith
SIGNATURE
CONTACT NO.
4066289
4066289
DATE
25 Feb 2011
25 Feb 2011
Reviewed by
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