Microbiology Laboratory Manager

As a manufacturer of sterile parenteral products, compliance to microbial requirements at

all stages of production is critical to our process. To do this we require trained

microbiologists and laboratory assistants who understand the basic essential components of

the science of microbiology. These resources (intellectual, skills and equipment) must be

managed to ensure an efficient microbiological service, which complies with GMP and GLP

principles whist confirming the application of parenteral control and product quality

assurance.

Duties:

Ensuring effective design, sampling and monitoring of all microbiological

requirements e.g Environmental Monitoring, Water, Raw Material and Product

Bioburden testing and Bacterial Endotoxin (LAL) determinations, Raw Material

and Final Product Biological Assays and Sterility Testing, for the FKMSA Site.

Development/Update and implementation of written procedures and validation

protocols, where required.

Ensuring all documentation and records are logged and up to date in the

appropriate logbooks, report sheets etc.

Requisition and controlled use of consumable goods and equipment through the

implementation of a capex compilation, budget and budget planning.

Ensuring that the maintenance, validation and calibration of all microbiology

laboratory equipment are performed as required.

Overseeing the completion of all microbiological validation and stability testing

requirements

Ensuring the implementation of GMP and GLP and Good Housekeeping Practices

in the laboratory, to ensure correct test performance which will yield valid

results, satisfy clothing requirements, and ensure cleaning is to the standards

required for each area class.

Approval for release of all microbiology related test results.

Upgrading of all test methods, equipment and facilities to ensure continued

compliance to current standards.

Problem solving to resolve out of specification results.

Monthly report on department output indication microbiological control of factory

site.

Monitoring and ensuring internal and external audit compliance to both

regulatory requirements and standards.

Administrative duties to ensure easy retrieval of test results, reports, protocols,

etc.

Responsible to perform investigations in the area of responsibility, with the

support of the tool Kabitrack

From time to time carry out other jobs within the department / factory, which

are consistent with the grade, qualification and training of the incumbent.

Budget and Cost Control

Control and optimise the cost within the department

Set quality and performance KPIs for the department and monitor the

departmental performance on a defined frequency

Continuously improve processes to introduce World Class Manufacturing practices

within the business

Identify opportunities for productivity and efficiency improvements

Human Resources Management

Manage all personnel in the department including disciplinary procedures

Ensure that all personnel in the department is developed and trained as required

by the various job functions

Recruitment of staff

Staff development regarding identifying needs and opportunities

Performance Management evaluation

Review salaries and promotions if applicable

Implementation of equity plan as set out in the Employment Equity Policy

Competence

Requirements:

B.Sc Microbiology/Biotechnology or NTD/HNTD Microbiology/Medical Technology

5 years Working Experience in Microlab

3 years Team Management

Cleanroom Certification

Detailed knowledge of microbiological requirements (Environmental Monitoring,

Water, Raw Material and Product Bioburden testing)

Detailed knowledge about procedures and validation protocols

Reporting and Documentation Knowledge

Budget and Budget planning

Skills in correct use of laboratory equipment

Microbiological validation and Stability testing requirements

Release of microbiology products

Advanced GxP and Quality standards/procedures

Advanced GMP Principals