Officers – Method Validation QC (24 positions)

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

Who 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 cGMP, 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 3–5years 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.