Lead Pharmaceutical Microbiologist – Method Dev & CAPA Expert

Placements24; Klerksdorp; Sur place; ZAR 900 000 - 1 300 000; Plein temps

Résumé du poste

Placements24 is seeking a Senior Pharmaceutical Microbiologist to lead the microbiology laboratory operations in Klerksdorp, North West, SA. This pivotal role oversees all microbiological testing and environmental monitoring to ensure product safety and regulatory compliance.

The Senior Microbiologist will drive method development, validation, and CAPA investigations, upholding QC integrity. You will lead staff, ensure GMP/ISO 17025 compliance, and collaborate with QA and Production to address

Qualifications

• MSc or PhD in Microbiology, Biotechnology, or related life science field.
• 6+ years of experience in pharmaceutical microbiology, preferably GMP.
• Expertise in microbial identification, enumeration, sterility testing and endotoxin testing.
• Strong knowledge of environmental monitoring strategies and microbial risk assessment.
• Experience in method development, validation, and troubleshooting.
• Good understanding of regulatory guidelines and pharmacopoeias.
• Strong analytical, problem-solving, and leadership skills.
• Ability to work independently and manage multiple projects in Klerksdorp, SA.
• Must be eligible to work in South Africa.

Responsabilités

• Supervise and perform microbiological tests on raw materials, finished products, and environmental samples.
• Develop, validate, and implement new microbiological methods and procedures.
• Conduct environmental monitoring programs (air, water, surfaces) and interpret results.
• Lead investigations into microbial contamination excursions and CAPAs.
• Ensure GMP/ISO 17025 compliance and pharmacopoeial requirements.
• Maintain laboratory equipment, including incubators, autoclaves, and microscopes.
• Train and mentor junior microbiology staff.
• Prepare reports and documentation related to microbiological testing and compliance.
• Collaborate with QA and Production to address microbiological concerns.

Connaissances

Microbiological identification

Enumeration techniques

Sterility testing

Endotoxin testing

Environmental monitoring

Method development

Validation

Troubleshooting

Regulatory guidelines

Leadership

Communication

Formation

MSc or PhD in Microbiology/Biotechnology or related life science

Description du poste

Placements24 is seeking a Senior Pharmaceutical Microbiologist to lead the microbiology laboratory operations in Klerksdorp, North West, SA. This pivotal role oversees all microbiological testing and environmental monitoring to ensure product safety and regulatory compliance.

The Senior Microbiologist will drive method development, validation, and CAPA investigations, upholding QC integrity. You will lead staff, ensure GMP/ISO 17025 compliance, and collaborate with QA and Production to address