About the Role
Our client, a leading pharmaceutical company with a strong commitment to quality and safety, is seeking a Senior Pharmaceutical Microbiologist for their advanced laboratory in Sandton . This critical role involves overseeing and conducting microbiological testing to ensure the safety and quality of pharmaceutical products, raw materials, and manufacturing environments. The ideal candidate will have extensive experience in pharmaceutical microbiology, a deep understanding of GMP, and expertise in aseptic techniques and environmental monitoring. You will play a key role in maintaining compliance with regulatory standards and protecting public health. This position offers a significant opportunity to lead and contribute to the microbiological quality assurance of life-saving medicines. We are looking for a dedicated professional committed to scientific excellence and rigorous quality standards.
Key Responsibilities
- Plan, execute, and interpret a wide range of microbiological tests on raw materials, finished products, water systems, and manufacturing environments.
- Conduct environmental monitoring (air, surface, personnel) in cleanroom facilities and interpret results to assess contamination risks.
- Perform microbial enumeration and identification tests, including sterility testing and microbial limit tests.
- Investigate out-of-specification (OOS) and out-of-trend (OOT) microbial results, identify root causes, and recommend corrective actions.
- Develop, validate, and implement new microbiological methods and protocols.
- Ensure compliance with current Good Manufacturing Practices (GMP), pharmacopeial standards (e.g., USP, EP), and regulatory guidelines.
- Maintain accurate and detailed laboratory records, prepare reports, and review data for accuracy and completeness.
- Operate and maintain microbiological laboratory equipment, ensuring proper calibration and functioning.
- Train and mentor junior microbiologists and laboratory technicians.
- Participate in internal and external audits related to microbiological quality.
Requirements
- Master's or Ph.D. degree in Microbiology, Applied Microbiology, or a related life science field.
- Minimum of 5 years of hands-on experience in pharmaceutical microbiology, preferably in a QC or R&D setting.
- In-depth knowledge of GMP principles and regulatory requirements pertaining to pharmaceutical microbiology.
- Proven experience with aseptic techniques, environmental monitoring, and sterility testing.
- Proficiency in various microbiological techniques, including media preparation, microbial culturing, and identification methods.
- Experience with bioburden testing, endotoxin testing (LAL), and microbial limit testing.
- Strong analytical and problem-solving skills, with meticulous attention to detail.
- Excellent written and verbal communication skills for reporting and documentation.
- Ability to work independently and as part of a team in a fast-paced laboratory environment.
- Familiarity with laboratory information management systems (LIMS) is a plus.
Benefits
- Our client offers a competitive salary and comprehensive benefits package, including medical aid, a pension fund, and opportunities for professional development and continuous learning.
- This position based in Sandton offers exposure to advanced microbiological techniques and challenges.
- Join a company dedicated to ensuring the highest standards of pharmaceutical quality and safety.
- Our client provides a collaborative and supportive work environment where your expertise in microbiology is highly valued and essential to patient care.