QC Analyst – Raw Materials (4 Positions) Jobs
Work Hours: Full-time, 08 hours per day
Salary:
Attractive
Job Deadline: 12 May 2025
Number of Jobs: 04
Hiring Entity: Dei BioPharma
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| Dei BioPharma |
Location: In Uganda
Job Details:
The QC Analyst Raw Materials is responsible for the sampling, testing and release of raw materials used in pharmaceutical manufacturing, ensuring they meet established quality standards and specifications. The analyst performs physical, chemical, and instrumental analyses (e.g., HPLC, UV, IR) in accordance with pharmacopeial monographs (USP, BP, Ph. Eur.), internal procedures, and current Good Manufacturing Practices (cGMP). The role also includes preparation of test solutions, calibration of instruments, documentation of results, and generation of Certificates of Analysis (CoAs). The ideal candidate must have a strong analytical background, attention to detail and experience in a GMP-compliant quality control laboratory.
Key Duties and Responsibilities:
- Receive, log and prepare samples of incoming raw materials in accordance with approved procedures
- Perform physical, chemical and where applicable, instrumental tests (e.g., HPLC, UV, IR) on raw materials in line with pharmacopoeial standards (USP, BP, Ph. Eur.).
- Conduct tests strictly following validated analytical methods, standard operating procedures (SOPs) and compendial monographs.
- Accurately record all raw data, test results and observations in lab notebooks or approved worksheets and generate Certificates of Analysis (CoAs) for approved materials.
- Identify and document any non-conformances or OOS results and initiate appropriate deviation reports and investigations.
- Operate, calibrate and maintain analytical instruments and equipment used in testing raw materials, ensuring fitness for use.
- Prepare reagents, reference standards and volumetric solutions used in analysis ensuring traceability and compliance with specifications.
- Participate in internal audits, continuous quality improvement initiatives, and training sessions aimed at enhancing laboratory efficiency and compliance.
Academic Qualifications:
- Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Analytical Chemistry, Industrial Chemistry or a closely related discipline from a recognized institution.
- Postgraduate qualifications or certifications in Quality Control, Analytical Method Development or Regulatory Sciences 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 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.
Application procedure
Interested and qualified? click here
Posting Date: 2025-05-09
 Jobs at Dei BioPharma){kind=link}