Brief Job Description:

• Leading, maintaining and continuously improving the Quality Management System (QMS) in line with international cGMP, GDP and GSP standards
• Acting as a registered Company Pharmacist, fulfilling all legal and regulatory responsibilities of the role, including the release of finished pharmaceutical products to the market
• Ensuring that all processes, specifications, instructions and results comply with the registered dossiers and with national and international GMP, GSP and GDP regulations
• Authorizing written procedures and their amendments, including SOPs, cleaning and operating procedures, specifications, analytical methods, validation/qualification and stability protocols, and batch and packaging instructions and records
• Managing, reviewing and approving the calibration and qualification of equipment, instruments, facilities and utilities, and the validation of manufacturing processes and cleaning procedures
• Reviewing batch records, packaging records and analytical testing records, and approving or rejecting starting materials, packaging materials, intermediates, bulk and finished products
• Qualifying, approving and monitoring manufacturers of raw materials, intermediates, packaging materials and finished products, and participating in external audits of vendors and service providers
• Conducting regular self-inspections and internal audits, managing inspections by authorities and customers, and ensuring timely closure of resulting CAPAs
• Managing, investigating and closing market complaints and managing product recalls, ensuring timely response to customers and regulatory authorities
• Ensuring timely preparation, review and approval of Product Quality Review (PQR) reports
• Preparing, executing, controlling and monitoring the Quality Assurance CAPEX and OPEX budget
• Acting as the back-up QPPV in the absence of the QPPV
• Leading and developing the Quality Assurance team
  • Providing functional and disciplinary leadership
  • Ensuring regular and effective cGMP and GDP training of all staff
  • Promoting a strong quality culture across pharmaceutical operations

Qualifications and Experience:
Must Have: Minimum Requirements
To be considered, these minimum requirements must be evident on your resume.

• Education: Bachelor of Pharmacy degree
• Registered as a Pharmacist in the Republic of Kenya
• A minimum of 5 years’ experience in the Pharmaceutical Industry, of which at least 3 years should be in a similar position
• Expert understanding of local and international regulations and standards for cGMP, GDP and GSP
• Excellent leadership, reporting and organizational skills, with the ability to design procedures and influence as a team player
• Self-driven and structured, able to work under minimal supervision, resolve problems in a timely manner and handle high work pressure
• Proficient computer skills: MS Word, MS Excel and MS PowerPoint; proficiency in English