6 QC Officers – Microbiology
2025-05-09T09:04:32+00:00
Dei BioPharma
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https://deibiopharma.com/
FULL_TIME
Matugga
Uganda
00256
Uganda
Healthcare
Healthcare
2025-05-12T17:00:00+00:00
Uganda
8
Job Summary:
The QC Officer Microbiology is responsible for performing microbiological testing of raw materials, finished products, water systems, and environmental samples in accordance with pharmacopeial standards, validated methods and current Good Manufacturing Practices (cGMP). The role includes microbial limit testing, sterility testing, endotoxin testing, environmental monitoring, and identification of microbial contaminants using conventional and rapid methods. The officer is expected to maintain accurate records, calibrate and operate lab equipment (e.g., autoclaves, laminar flow hoods, incubators) and support validation, qualification, and cleanroom compliance activities. The ideal candidate should have a solid foundation in pharmaceutical microbiology and demonstrate strict adherence to aseptic techniques, data integrity and regulatory requirements.
Key Duties and Responsibilities:
- Conduct routine microbiological monitoring of cleanrooms, production areas and equipment to ensure aseptic conditions.
- Analyze purified water and compressed air samples for microbial contamination according to pharmacopeial standards (USP, BP).
- Perform sterility tests for sterile drug products under validated aseptic conditions as per approved protocols.
- Evaluate the total viable aerobic count (TAMC/TYMC) and identify specified microorganisms in raw materials, intermediates and finished products according to compendial methods.
- Prepare and sterilize culture media and perform growth promotion tests to ensure suitability of the media for microbiological use.
- Participate in cleanroom qualification, HVAC validation and media fill/aseptic process simulation exercises.
- Estimate microbial load in non-sterile products, water samples and environmental monitoring samples prior to sterilization.
- Operate, calibrate and maintain microbiology lab instruments such as autoclaves, incubators, laminar air flow cabinets and colony counters.
- Maintain strict adherence to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and microbiological safety protocols within the laboratory.
- Maintain microbiology laboratory documentation and practices in a state of readiness for internal and regulatory audits (e.g., NDA, WHO, GMP inspectors).
Academic Qualifications:
- Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Biochemistry, or a closely related discipline from a recognized institution.
- Postgraduate qualifications or certifications in Quality Control or Microbiology will be an added advantage.
Experience and Competencies
- Minimum of 3–5 years of hands-on experience in an analytical laboratory, preferably within the pharmaceutical or biopharmaceutical industry.
- Proven experience in analytical method development, optimization, validation, and transfer in accordance with ICH guidelines (Q2(R2)).
- Direct involvement in the preparation and execution of method validation protocols and reports, and familiarity with regulatory expectations (e.g., NDA Uganda, WHO PQ, US FDA).
- Strong understanding of method validation parameters: accuracy, precision, specificity, linearity, range, robustness, LOD/LOQ and system suitability.
- Familiarity with compendial methods (USP, BP, Ph. Eur.) and capability to adapt and validate these as per internal product requirements.
- Experience in using analytical instrumentation such as HPLC, UV-Vis spectrophotometer, FTIR, and Dissolution Testers.
- Prior exposure to Good Laboratory Practices (GLP), data integrity principles (ALCOA+), and current Good Manufacturing Practices (cGMP).
- Demonstrated participation in regulatory or internal audits with a focus on analytical compliance.
Conduct routine microbiological monitoring of cleanrooms, production areas and equipment to ensure aseptic conditions. Analyze purified water and compressed air samples for microbial contamination according to pharmacopeial standards (USP, BP). Perform sterility tests for sterile drug products under validated aseptic conditions as per approved protocols. Evaluate the total viable aerobic count (TAMC/TYMC) and identify specified microorganisms in raw materials, intermediates and finished products according to compendial methods. Prepare and sterilize culture media and perform growth promotion tests to ensure suitability of the media for microbiological use. Participate in cleanroom qualification, HVAC validation and media fill/aseptic process simulation exercises. Estimate microbial load in non-sterile products, water samples and environmental monitoring samples prior to sterilization. Operate, calibrate and maintain microbiology lab instruments such as autoclaves, incubators, laminar air flow cabinets and colony counters. Maintain strict adherence to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and microbiological safety protocols within the laboratory. Maintain microbiology laboratory documentation and practices in a state of readiness for internal and regulatory audits (e.g., NDA, WHO, GMP inspectors).
Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Biochemistry, or a closely related discipline from a recognized institution. Postgraduate qualifications or certifications in Quality Control or Microbiology will be an added advantage.
JOB-681dc5208cba2
Vacancy title:
6 QC Officers – Microbiology
[Type: FULL_TIME, Industry: Healthcare, Category: Healthcare]
Jobs at:
Dei BioPharma
Deadline of this Job:
Monday, May 12 2025
Duty Station:
Matugga | Uganda | Uganda
Summary
Date Posted: Friday, May 9 2025, Base Salary: Not Disclosed
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JOB DETAILS:
Job Summary:
The QC Officer Microbiology is responsible for performing microbiological testing of raw materials, finished products, water systems, and environmental samples in accordance with pharmacopeial standards, validated methods and current Good Manufacturing Practices (cGMP). The role includes microbial limit testing, sterility testing, endotoxin testing, environmental monitoring, and identification of microbial contaminants using conventional and rapid methods. The officer is expected to maintain accurate records, calibrate and operate lab equipment (e.g., autoclaves, laminar flow hoods, incubators) and support validation, qualification, and cleanroom compliance activities. The ideal candidate should have a solid foundation in pharmaceutical microbiology and demonstrate strict adherence to aseptic techniques, data integrity and regulatory requirements.
Key Duties and Responsibilities:
- Conduct routine microbiological monitoring of cleanrooms, production areas and equipment to ensure aseptic conditions.
- Analyze purified water and compressed air samples for microbial contamination according to pharmacopeial standards (USP, BP).
- Perform sterility tests for sterile drug products under validated aseptic conditions as per approved protocols.
- Evaluate the total viable aerobic count (TAMC/TYMC) and identify specified microorganisms in raw materials, intermediates and finished products according to compendial methods.
- Prepare and sterilize culture media and perform growth promotion tests to ensure suitability of the media for microbiological use.
- Participate in cleanroom qualification, HVAC validation and media fill/aseptic process simulation exercises.
- Estimate microbial load in non-sterile products, water samples and environmental monitoring samples prior to sterilization.
- Operate, calibrate and maintain microbiology lab instruments such as autoclaves, incubators, laminar air flow cabinets and colony counters.
- Maintain strict adherence to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and microbiological safety protocols within the laboratory.
- Maintain microbiology laboratory documentation and practices in a state of readiness for internal and regulatory audits (e.g., NDA, WHO, GMP inspectors).
Academic Qualifications:
- Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Biochemistry, or a closely related discipline from a recognized institution.
- Postgraduate qualifications or certifications in Quality Control or Microbiology will be an added advantage.
Experience and Competencies
- Minimum of 3–5 years of hands-on experience in an analytical laboratory, preferably within the pharmaceutical or biopharmaceutical industry.
- Proven experience in analytical method development, optimization, validation, and transfer in accordance with ICH guidelines (Q2(R2)).
- Direct involvement in the preparation and execution of method validation protocols and reports, and familiarity with regulatory expectations (e.g., NDA Uganda, WHO PQ, US FDA).
- Strong understanding of method validation parameters: accuracy, precision, specificity, linearity, range, robustness, LOD/LOQ and system suitability.
- Familiarity with compendial methods (USP, BP, Ph. Eur.) and capability to adapt and validate these as per internal product requirements.
- Experience in using analytical instrumentation such as HPLC, UV-Vis spectrophotometer, FTIR, and Dissolution Testers.
- Prior exposure to Good Laboratory Practices (GLP), data integrity principles (ALCOA+), and current Good Manufacturing Practices (cGMP).
- Demonstrated participation in regulatory or internal audits with a focus on analytical compliance.
Work Hours: 8
Experience in Months: 36
Level of Education: bachelor degree
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