Quality Assurance Specialist (800767)

Purpose The Quality Assurance Specialist develops the logistics centre’s quality management system and is the legal representative of the ICRC's pharmaceutical operations to National Drug Regulatory authorities. Accountabilities & Functional responsibilities Contributes to the implementation and continous improvement of the Quality Management System, including SOPs (Standard Operating Procedures), KPIs(Key Performance Indicators), internal audits, training, change control, deviations and CAPA (Corrective and Preventive Action) systems. This should be in compliance with WHO(World Health Organisation) Good Distribution Practices (GDP) for medicinal products for human use; Supports the Head Pharmacist and Quality Assurance Pharmacists in ensuring effective implementation of GDP requirements across operations; Develops, reviews, revises and maintains quality system documentation, including SOPs and related controlled documents. Provides technical guidance to other units in SOP development and compliance; Participates in GDP and GMP (Good Manufacturing Practice) audits under the guidance of the Quality Assurance Pharmacist; Supports GDP training programs for staff involved in the medical supply chain and contributes to fostering a quality-focused culture within the organisation; Contributes to reporting on quality performance indicators and compliance metrics as required; Acts as the Liaison between the Pharmacy & Poisons Board (PPB), the director of Veterinary Services, other regulatory bodies and the Logistics Support Center, facilitating follow-up and coordination on the processing of import and export permits for healthcare, veterinary pharmaceuticals and medical devices; Ensures that all suppliers and healthcare products of healthcare goods are compliant with Pharmacy and Poisons board requirements; Organizes for the disposal of damaged and obsolete drugs in liaison with Pharmacy and Poisons Board; Releases or rejects products following cold chain breakdowns in accordance with established procedures and ensures appropriate reporting and documentation of incidents; Participates in the management of deviations, complaints, and CAPA processes, including cold chain excursions; Participates and supports qualification and validation activities for equipment, systems, and processes to ensure compliance with GDP requirements; Provides technical support to the Medical Purchasers on the quality related issues including reviewing the drafts for the Global Quality Comparison Table; Lead, supervise, mentor and coach team members.

Professional experience required Bachelor's Degree in Pharmacy from a recognized university; Must be a registered Pharmacist with the Pharmacy & Poisons Board, Ministry of Health in the Republic of Kenya; 10 to 12 years experience in the quality assurance unit of a pharmaceutical company; Must have good knowledge of Ministry of Health Policies including national and international drug laws and policies; Advanced computer skills (Word, Excel, Powerpoint); Experience in risk management; Strong leadership skills and supervision experience; High organizational and analytical skills; Able to develop and sustain a network of key contacts.