Head, Drug Quality Control Laboratory
The job holder provides strategic leadership and expert oversight to the Drug Quality Control Laboratory, ensuring it plays a critical role in supporting national healthcare policies and public health goals. This position is responsible for overseeing all laboratory operations to ensure the quality, potency, purity, and stability of pharmaceutical products available to the public. The Head of Quality Drug Laboratory will develop and implement comprehensive quality assurance programs and rigorous testing protocols, ensuring compliance with both national and international regulatory standards.
KeyRoles and Responsibilities
- 1. Provide strategic leadership and direction to the Drug Quality Control Laboratory team.
- 2. Manage laboratory operations, including staffing, resource allocation, and budget management.
- 3. Oversee the testing of pharmaceutical products to assess their quality, potency, purity, and stability.
- 4. Develop and implement robust testing protocols and methodologies in accordance with regulatory requirements.
- 5. Oversee efficacy testing of drugs to ensure they meet established standards and specifications for therapeutic effectiveness.
- 6. Utilize appropriate analytical techniques and instruments to evaluate drug performance and efficacy.
- 7. Ensure compliance with regulatory standards, pharmacopeial requirements, and industry guidelines in all laboratory testing activities.
- 8. Monitor and enforce adherence to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) within the laboratory.
- 9. Lead the analysis of drug samples received from various sources, including manufacturers, distributors, and regulatory agencies.
- 10. Investigate any variations or discrepancies in drug samples and determine their root causes through comprehensive analysis.
- 11. Oversee the maintenance of accurate records of laboratory testing procedures, results, and observations.
- 12. Oversee the preparation of detailed reports documenting the findings of drug quality control tests and any deviations from expected standards.
- 13. Identify opportunities for process optimization and quality enhancement within the laboratory.
- 14. Implement corrective and preventive actions to address any deficiencies or non-conformities identified during quality control testing.
- 15. Draw up budgets overall and for the department's programmes according to the applicable legal requirements of the country and to monitor and evaluate the budget management.
- 16. Maintain coordination and cooperation with other national and international units and organizations cornered with drugs, medicines, and pharmaceuticals control and with other units and administrative levels of the relevant sector.
- 17. Ensure that the minimal safety conditions for the work are compliant within the laboratory, including accident prevention and treatment (first aid), as well as the appropriate disposal of waste.
- 18. Ensure the adequacy of existing staffing, management and training procedures is reviewed periodically.
- 19. Ensure adequate information flow between staff at all levels and ensure the traceability of the sample from receipt, throughout the stages of testing, to the completion of the analytical test report.
- 20. Manage the team, provide necessary guidance, and prepare plans for staff training & development.
- 21. Perform other duties as requested to meet the ongoing organizational needs.
Bachelor’s Degree in Pharmaceutical Sciences/ Pharmacy from a recognized university. Master's in related field preferred.
Required Certification/ LicensureSubject to Healthcare Specialties Deparment regulations.
Minimum 10 years’ experience in relevant role, out of which 4 years in Managerial or Supervisory capacity
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).