Dei BioPharma Ltd
Announcement Number: DB/05/2025/QC03
Position Title: Officers – Method Validation QC (24 positions)
Opening Period: 05/05/2025 – 05/12/2025
Series/Grade: L (3)
Salary: Competitive
May Apply: All Interested Applicants
Duration Appointment: Indefinite, subject to successful completion of probationary period
Supervisory Position: None
Job Summary:
The QC Officer Method Validation is responsible for the development, validation, verification, and transfer of analytical methods used in the quality control of pharmaceutical raw materIals, intermediates, and finished products. The role ensures that all analytical methods meet regulatory requirements as outlined in ICH Q2(R2) guidelines with a focus on parameters such as accuracy, precision, specificity, linearity, robustness, and system suitability. The officer will execute validation protocols, prepare comprehensive reports and support analytical lifecycle management.
The ideal candidate should have hands-on experience with advanced instrumentation (e.g., HPLC, UV-Vis, FTIR), strong documentation skills and a thorough understanding of GMP, GLP and regulatory expectations from authorities such as NDA, WHO PQ and US FDA.
Key Duties and Responsibilities:
1. Design, optimize and develop new analytical methods for raw materials, in-process materials and finished pharmaceutical products
2. Prepare, execute and document method validation protocols for analytical procedures as per ICH Q2(R2) guidelines covering parameters such as accuracy, precision, linearity, range, specificity, LOD, LOQ, robustness and system suitability.
3, Participate in analytical method transfer between development and QC units or from third parties.
4. Perform method verification as required to confirm reproducibility in the receiving lab.
5. Operate and maintain analytical instruments such as HPLC, UV-Vis spectrophotometers, FTIR, dissolution testers and other chromatography-based platforms.
6. Ensure all method validation activities are conducted under current Good Manufacturing Practices (CGMP), Good Laboratory Practices (GLP) and are audit-ready at all times.
7. Record and review raw data, chromatograms, and test results in accordance with ALCOA+ principles.
8. Work closely with R&D, production, QA and regulatory teams to support product development timelines, regulatory submissions and continuous improvement initiatives.
9. Participate in change control evaluations related to analytical methods.
10. Prepare and present validation documentation during internal audits and external inspections (e.g., NDA, WHO PQ, GMP regulatory bodies).
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. Experience in using analytical instrumentation such as HPLC, UV-Vis spectrophotometer, FTIR, and Dissolution Testers.
5. Prior exposure to Good Laboratory Practices (GLP), data integrity principles (ALCOA+), and current Good Manufacturing Practices (CGMP).
6. 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
