Senior Pharmaceutical Microbiologist

Placements24; Upington; In loco; ZAR 900.000 - 1.200.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary + bonus

Comprehensive medical aid

Retirement savings plan

Professional development opportunities

Relocation assistance

Descrizione del lavoro

Placements24 is seeking a Senior Pharmaceutical Microbiologist in Upington, Northern Cape. You will lead microbiological testing across materials, processes, products and environmental samples, ensuring GMP/GLP compliance.

The role covers method development, validation, and regulatory alignment, while guiding junior staff. The ideal candidate has a strong background in microbiology, regulatory standards, and lab management, with a track record in quality investigations and environmental

Competenze

• Master's or Ph.D. in Microbiology, Medical Microbiology, or related life science.
• Minimum of 6 years of progressive experience in microbiological testing in pharma/biotech.
• In-depth knowledge of microbial identification, microbial limits, sterility, endotoxin testing (LAL), and environmental monitoring.
• Strong GMP/regulatory understanding for microbiology.
• Experience with method validation and OOS investigations.
• Excellent analytical, problem-solving, and leadership abilities.

Mansioni

• Perform and interpret microbiological tests on materials, in-process samples, finished products, and environmental samples.
• Develop, validate, and implement microbiological methods per regulatory standards.
• Ensure GMP/GLP compliance and adherence to regulatory guidelines (USP, EP, FDA, SAHPRA).
• Investigate OOS/OOT results, perform root cause analysis, and implement CAPAs.
• Manage microbiology lab operations including equipment QC and inventory.
• Provide training to junior staff and collaborate with QA, Manufacturing, and R&D.

Conoscenze

Microbiology

Leadership

Analytical thinking

Regulatory compliance

LIMS

Formazione

Master's or PhD in Microbiology

Strumenti

LIMS

Environmental monitoring equipment

Descrizione del lavoro

About the Role

Our client, a leading pharmaceutical company renowned for its commitment to quality and innovation, is seeking an experienced Senior Pharmaceutical Microbiologist. This critical role, based in Upington, Northern Cape, involves leading and executing microbiological testing to ensure the safety and efficacy of pharmaceutical products and manufacturing environments. The ideal candidate will possess extensive expertise in microbiological techniques, regulatory compliance, and laboratory management. This is an exceptional opportunity to contribute significantly to public health by upholding the highest microbiological standards within a reputable organization.

Key Responsibilities

• Perform and interpret a wide range of microbiological tests on raw materials, in-process samples, finished products, and environmental monitoring samples.


• Develop, validate, and implement new microbiological methods in line with regulatory requirements and company standards.


• Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant pharmacopoeial and regulatory guidelines (e.g., USP, EP, FDA, SAHPRA).


• Investigate and resolve Out-of-Specification (OOS) and Out-of-Trend (OOT) results, including root cause analysis and implementation of corrective actions.


• Manage and maintain the microbiology laboratory, including equipment calibration, qualification, and inventory control.


• Provide technical guidance and training to junior microbiologists and laboratory personnel.


• Conduct risk assessments related to microbiological contamination and contamination control strategies.


• Collaborate with Quality Assurance, Manufacturing, and R&D departments on microbiological aspects of product development, process validation, and facility design.


• Stay current with advancements in microbiology and related regulatory changes.

Requirements

• Master's degree or Ph.D. in Microbiology, Medical Microbiology, or a related life science discipline.


• Minimum of 6 years of progressive experience in microbiological testing within the pharmaceutical or biotechnology industry.


• In-depth knowledge of microbial identification techniques, microbial limits testing, sterility testing, endotoxin testing (LAL), and environmental monitoring.


• Strong understanding of pharmaceutical GMP and regulatory requirements related to microbiology.


• Proven experience in method validation and OOS investigations.


• Excellent analytical, problem-solving, and decision-making skills.


• Strong leadership, team management, and communication abilities.


• Proficiency in laboratory information management systems (LIMS) and data analysis.

Benefits

• Competitive annual salary and bonus structure.


• Comprehensive medical aid, retirement savings plan, and life assurance.


• Opportunities for professional development, including attending conferences and specialized training.


• Access to modern laboratory facilities and advanced scientific equipment.


• Relocation assistance may be available for qualified candidates.


• A challenging and rewarding role contributing to patient safety in Upington, Northern Cape and beyond.