QC Officers – Microbiology (6 positions)

Dei BioPharma Ltd

Announcement Number: DB/05/2025/QC02

Position Title: QC Officers – Microbiology (6 positions)

Opening Period: 05/05/2025 – 05/12/2025

Series/Grade: L (3)

Salary: Competitive

Who May Apply: All Interested Applicants

Duration Appointment: Indefinite, subject to successful completion of probationary period

Supervisory Position: None

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:

1. Conduct routine microbiological monitoring of cleanrooms, production areas and equipment to ensure aseptic conditions.

2. Analyze purified water and compressed air samples for microbial contamination according to pharmacopeial standards (USP, BP).
3. Perform sterility tests for sterile drug products under validated aseptic conditions as per approved protocols.
4. Evaluate the total viable aerobic count (TAMC/TYMC) and identify specified microorganisms in raw materials, intermediates and finished products according to compendial methods.
5. Prepare and sterilize culture media and perform growth promotion tesis to ensure suitability of the media for microbiological use.

6. Participate in cleanroom qualification, HVAC validation and media fill aseptic process simulation exercises.

7. Estimate microbial load in non-sterile products, water samples and environmental monitoring samples prior to sterilization.

8. Operate, calibrate and maintain microbiology lab instruments such as autoclaves, incubators, laminar air flow cabinets and colony counters.

9. Maintain strict adherence to current Good Manufacturing Practices (CGMP), Good Laboratory Practices (GLP), and microbiological safety protocols within the laboratory.

10. Maintain microbiology laboratory documentation and practices in a state of readiness or internal and regulatory audits (e.g., NDA, WHO, GMP inspectors)

Academic Qualifications:

1. Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Biochemistry, or a closely related discipline from a recognized institution.

2. Postgraduate qualifications or certifications in Quality Control or Microbiology will be an added advantage.

Experience and Competencies

1. Minimum of 3-5 years of hands-on experience in an analytical laboratory, preferably within the pharmaceutical or biopharmaceutical industry.

2. Proven experience in analytical method development, optimization, validation, and transfer in accordance with ICH guidelines (Q2(R2)).

3. 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).

4. Strong understanding of method validation parameters: accuracy, precision, specificity, linearity, range, robustness, LOD/LOQ and system suitability.

5. Familiarity with compendial methods (USP, BP, Ph. Eur.) and capability to adapt and validate these as per internal product requirements.
6. Experience in using analytical instrumentation such as HPLC, UV- Vis spectrophotometer, FTIR, and Dissolution Testers.
7. Prior exposure to Good Laboratory Practices (GLP), data integrity principles (ALCOA+), and current Good Manufacturing Practices (CGMP).

8. Demonstrated participation in regulatory or internal audits with a focus on analytical compliance.

All applicants under consideration will be required to pass medical and security certifications.

EQUAL OPPORTUNITY EMPLOYER: Dei BioPharma Ltd, provides equal opportunity and fair and equitable treatment in employment to all people without regard to race, color, religion, sex, national origin, age, disability, political affiliation or marital status.

HOW TO APPLY:

All interested candidates who meet the required qualifications and experience are invited to submit their CVs, Cover Letter & Academic documents (addressed to the Human Resources Manager)

All Application documents should be merged as one document in PDF or DOC / DOCX, which should not exceed 10MB

Applications should be sent by email to recruitment@deibiopharma. com with the JOB TITLE IN THE SUBJECT LINE

Should you not hear from us within twenty one (21) days from the closing date of this advertisement, you may consider your application to be unsuccessful

Deadline: 12th May 2025 by 5:00PM

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