- Support the Head, Quality Management with the coordination and supervision of planning, implementation, maintenance and improvement of the quality management system in NDA in conformity with ISO 9001 and ISO 17025 standards and other relevant and applicable international standard and WHO guidelines.
- Assist the Quality manager in organizing and conducting of management review meetings in accordance with ISO 9001 and prepare reports for submission.
- Actively coordinate the preparation, control and revision of controlled documents at NDA.
- Ensure effective coordination of preparation and maintenance of controlled quality management systems documents internally documented, their back up and records.
- Actively participate in reviewing and updating all quality management systems documents of NDA.
- Establish and maintain procedures for the identification, collection, indexing, retrieval, storage, maintenance and disposal of, and access to all quality and technical/scientific records.
- Participate in planning, organizing, conducting and controlling internal audits, dealing with non- conformities, monitoring and evaluation of corrective and preventive actions and complaints.
- Actively participate in the preparation of annual, activity plans and accompanying annual budgets for the unit.
- Perform any other duties assigned by the supervisor from time to time
- The applicant should hold a Bachelor’s degree in Pharmacy, Chemistry, Biomedical Sciences, Human or Veterinary Medicine.
- At least five years’ experience in quality management of a reputable organization, preferably a medicines regulation, research or health institution
- Practical experience in documentation system development and control.
- Proficiency in Quality control/ quality assurance of medicines, public health products, medical devices and other related health care products.
- Hold a Certificate of ISO 9001 qualified Lead auditor and or certificate of ISO/IEC 17025 qualified lead Assessor
- Certificate in Good Manufacturing Practice
- Good knowledge of the national and international standards, norms and practices as they relate to regulation of drugs and other pharmaceuticals.
- Computer literacy skills i.e. Proficiency in MS word, MS Excel and MS access.
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