Senior Microbiologist - Pharmaceutical Quality Control

Placements24; Stellenbosch; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Competitive salary

Health and retirement benefits

Professional development

Stable work environment

Job summary

Placements24 seeks an experienced Senior Microbiologist to join the Quality Control department in Stellenbosch. You will oversee and execute microbiological testing for pharmaceutical products to ensure safety, efficacy, and regulatory compliance, and you will implement and validate robust microbial testing methods.

The ideal candidate holds an MSc or PhD in Microbiology or a related field with 5+ years in GMP/pharma, and strong familiarity with USP/EP methods, environmental monitoring, and

Qualifications

• MSc or PhD in Microbiology, Biotechnology, or related life science field.
• Minimum of 5 years of experience in pharmaceutical quality control or a GMP environment.
• Strong knowledge of microbial identification techniques, sterile filtration, and environmental monitoring.
• Experience with compendial methods (USP, EP) and microbial limit testing.
• Proficiency in aseptic techniques and operation of microbiological laboratory equipment.
• Excellent documentation skills and regulatory compliance knowledge.

Responsibilities

• Perform a wide range of microbiological tests on raw materials, in-process samples, and finished pharmaceutical products.
• Develop, validate, and implement new microbiological methods and protocols according to regulatory guidelines (FDA, EMA).
• Investigate deviations and microbial contamination events.
• Ensure GMP compliance and support quality systems.
• Train and mentor junior laboratory personnel in microbiological techniques.
• Prepare detailed reports for regulatory submissions and internal reviews.

Education

MSc or PhD in Microbiology, Biotechnology, or related life science field

Job description

About the Role

Our client is seeking an experienced Senior Microbiologist to join their Quality Control department in Stellenbosch . This critical role involves overseeing and executing microbiological testing for pharmaceutical products to ensure safety, efficacy, and compliance with regulatory standards. You will play a key role in maintaining the integrity of our client's product lines by implementing and validating robust microbial testing methods. The ideal candidate brings a wealth of knowledge in pharmaceutical microbiology, a keen eye for detail, and a commitment to upholding the highest quality standards within a regulated industry.

Key Responsibilities

• Perform a wide range of microbiological tests on raw materials, in-process samples, and finished pharmaceutical products.
• Develop, validate, and implement new microbiological methods and protocols according to regulatory guidelines (e.g., FDA, EMA).
• Investigate deviations, out-of-specification (OOS) results, and microbial contamination events.
• Ensure compliance with Good Manufacturing Practices (GMP) and other relevant quality systems.
• Train and mentor junior laboratory personnel on microbiological techniques and procedures.
• Prepare detailed reports and documentation for regulatory submissions and internal reviews.

Requirements

• M.Sc. or Ph.D. in Microbiology , Biotechnology, or a related life science field.
• Minimum of 5 years of experience in pharmaceutical quality control or a related GMP environment.
• Strong knowledge of microbial identification techniques, sterile filtration, and environmental monitoring.
• Experience with compendial methods (e.g., USP, EP) and microbial limit testing.
• Proficiency in aseptic techniques and the operation of microbiological laboratory equipment.
• Excellent documentation skills and a thorough understanding of regulatory compliance requirements.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health and retirement benefits package.
• Opportunities for professional development and advanced training.
• A stable and supportive work environment within a leading pharmaceutical company.