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
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