Microbiologist Lab Manager

at  Fresenius Kabi

Fresenius Kabi is a global healthcare company more than 40,500 employees worldwide.
We are dedicated to a higher purpose “caring for life” which drives excellence in everything we do.
The manufacturing plant in Port Elizabeth produces both small and large volume parenterals.
The purpose of this role 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.

COMPETENCE REQUIREMENTS

• BSc 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
• Hygiene Instructions
• Understanding SOP system
• Aseptic Manufacturing knowledge
• Managing Conflict
• Communication skills
• Understanding the environment in which you operate
• Understanding of the Quality management system ICH Q10
• B.Sc Microbiology/Biotechnology or NTD/HNTD
• Microbiology/Medical Technology
• 5 years working experience in pharmaceutical microbiology laboratory with 2 years supervisory/managerial experience.

• 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