Dawa Life Sciences Quality Assurance Manager Jobs in Kenya
Responsibilities
Lead, maintain, and continuously improve the Quality Management System (QMS) in line with international cGMP, GDP, and GSP standards.
Act as the registered Company Pharmacist, fulfilling all legal and regulatory responsibilities, including release of finished pharmaceutical products to the market.
Ensure all processes, specifications, instructions, and results comply with registered dossiers and national/international GMP, GSP, and GDP regulations.
Authorize written procedures and amendments, including SOPs, cleaning and operating procedures, specifications, analytical methods, validation/qualification and stability protocols, and batch/packaging instructions and records.
Manage, review, and approve calibration and qualification of equipment, instruments, facilities, and utilities, and validation of manufacturing processes and cleaning procedures.
Review batch records, packaging records, and analytical testing records; approve or reject starting materials, packaging materials, intermediates, bulk, and finished products.
Qualify, approve, and monitor manufacturers of raw materials, intermediates, packaging materials, and finished products; participate in external audits of vendors and service providers.
Conduct regular self‑inspections and internal audits; manage inspections by authorities and customers; ensure timely closure of CAPAs.
Manage, investigate, and close market complaints; oversee product recalls and ensure timely response to customers and regulatory authorities.
Prepare, review, and approve Product Quality Review (PQR) reports.
Prepare, execute, control, and monitor the Quality Assurance CAPEX and OPEX budget.
Act as back‑up QPPV in the absence of the QPPV.
Lead and develop the Quality Assurance team, providing functional
and disciplinary leadership.
Ensure regular and effective cGMP and GDP training of all staff.
Promote a strong quality culture across pharmaceutical operations.
Qualifications / Work Experience
Academic Bachelor of Pharmacy Degree.
Professional Registered Pharmacist in the Republic of Kenya.
Professional Minimum of five (5) years’ experience in the pharmaceutical industry, with at least three (3) years in a similar position.
Professional Expert understanding of local and international regulations and standards for cGMP, GDP, and GSP.
Professional Excellent leadership, reporting, and organizational skills, with ability to design procedures and influence as a team player.
Professional Self‑driven and structured, able to work under minimal supervision, resolve problems in a timely manner, and handle high work pressure.
Professional Proficient computer skills: MS Word, MS Excel, MS PowerPoint; proficiency in English.
How to Apply
For more information and job application details, see; Dawa Life Sciences Quality Assurance Manager Jobs in Kenya
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