Quality Assurance Manager

Dawa Life Sciences is dedicated to continuously upgrading its technologies and implementing robust processes to deliver best-in-quality products to its communities.

The Quality Assurance Manager is responsible for overseeing and enhancing the company's Quality Management System to meet international cGMP, GDP, and GSP standards. This includes acting as a registered Company Pharmacist, ensuring compliance with legal and regulatory requirements, and authorizing various procedures and their amendments. The role also involves managing the calibration and qualification of equipment, reviewing batch records, and approving materials and products to maintain high-quality standards.

1. Lead, maintain, and continuously improve the Quality Management System (QMS) in accordance with international cGMP, GDP, and GSP standards.
2. Act as the registered Company Pharmacist, fulfilling all legal and regulatory duties, including releasing finished pharmaceutical products to the market.
3. Ensure all processes, specifications, instructions, and results comply with registered dossiers and national/international GMP, GSP, and GDP regulations.
4. Authorize written procedures and their amendments, such as SOPs, cleaning and operating procedures, specifications, analytical methods, validation/qualification and stability protocols, and batch/packaging instructions and records.
5. Manage, review, and approve the calibration and qualification of equipment, instruments, facilities, and utilities, as well as the validation of manufacturing processes and cleaning procedures.
6. Review batch records, packaging records, and analytical testing records, and approve or reject starting materials, packaging materials, intermediates, bulk, and finished products.
7. Qualify, approve, and monitor manufacturers of raw materials, intermediates, packaging materials, and finished products, and participate in external audits of vendors and service providers.
8. Conduct regular self-inspections and internal audits, manage inspections by authorities and customers, and ensure timely closure of resulting Corrective and Preventive Actions (CAPAs).
9. Manage, investigate, and close market complaints and product recalls, ensuring timely responses to customers and regulatory authorities.
10. Ensure timely preparation, review, and approval of Product Quality Review (PQR) reports.
11. Prepare, execute, control, and monitor the Quality Assurance CAPEX and OPEX budget.
12. Act as the back-up Qualified Person for Pharmacovigilance (QPPV) in the absence of the primary QPPV.
13. Lead and develop the Quality Assurance team, providing functional and disciplinary leadership.
14. Ensure regular and effective cGMP and GDP training for all staff.
15. Promote a strong quality culture across all pharmaceutical operations.

1. Hold a Bachelor of Pharmacy degree.
2. Be a registered Pharmacist in the Republic of Kenya.
3. Possess a minimum of 5 years of experience in the Pharmaceutical Industry, with at least 3 years in a similar Quality Assurance management position.
4. Demonstrate expert understanding of local and international regulations and standards for cGMP, GDP, and GSP.
5. Exhibit excellent leadership, reporting, and organizational skills, with the ability to design procedures and collaborate effectively as a team player.
6. Be self-driven, structured, capable of working with minimal supervision, resolving problems promptly, and managing high work pressure.
7. Be proficient in computer skills, including MS Word, MS Excel, and MS PowerPoint, and proficient in English.