Job Summary 8430 views
Mar 27, 2015
Apr 26, 2015
Addis Ababa 
Career Level:
Senior Level (5+ years experience)
Employment Type:

Job Description

<strong>All Africa Leprosy Tuberculosis and rehabilitation training center (ALERT) would like to hire qualified candidates for the following post</strong><br /><strong>Position: </strong>Quality Assurance (QA) Officer<br /><strong>Department: </strong>Clinical Trials &amp; Laboratory management<br /><strong><em>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Job Summary</em></strong><ul style="list-style-type:circle"><li>Ensuring planning, coordination, and continuous improvement of processes and methods are established to control the quality of studies conducted at the institute</li><li>Responsible for ensuring clinical, pharmacy, laboratory and data management processes are conducted in accordance with guidelines, regulations and SOPs.</li><li>Develops, performs, and manages quality assurance activities and oversees systems &amp; study audits.</li></ul>&nbsp;<br /><strong><em>Essential Duties and Responsibilities</em></strong><br />-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Organize and lead overall activities in QA unit<br />-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Prepare and/or review QA documents and SOPs<br />-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Lead and/or assist in preparing SOPs and other relevant study documents in quality study management at the clinic, laboratory and pharmacy levels. &nbsp;<br />-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ensure that all processes contributing to the performance of clinical studies are conducted properly.<ul><li>Develop and maintain GCP/ICH compliant processes which control the quality of work and clinical trials conducted at the clinical site</li></ul>-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Monitor over study databases for the quality system.<br />-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Prepare and assist in preparing annual or interim reports and quality trending reports.<br />-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Act as internal auditor for reporting the status of the quality levels of staff, systems, services/processes and study records.<br />-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ensure that investigator, vendor, facility and system audits are conducted.<br />-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Evaluate quality events, incidents, queries, and complaints.<br />-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Document, keep up to date and communicate all related local and international clinical &amp; laboratory quality guidelines, legislations and compliance issues.<br />-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Compile and prepare study documents &amp; materials for submission to regulatory agencies when indicated.<br />-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Assume a lead role for the preparation, conduct, and responses to regulatory agency.<br />-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Assist/organize in providing training to the clinical &amp; laboratory staff<br />-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Lead all activities in preparing the clinical site and laboratories for accreditation<br />-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Troubleshoot activities in clinical studies.<br />-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Communicate any critical compliance risks noted from these activities to senior management.<br />-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Perform other related duties as assigned by team leaders and director&nbsp;

Job Requirement

<strong><u>QUALIFICATIONS REQUIRED </u></strong><br />&nbsp;<br /><strong>EDUCATION:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </strong><br />&nbsp;<br />1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Bachelors Degree or equivalent in clinical, laboratory or related Sciences&nbsp;<br />&nbsp;<br />Certificate Training:<ol><li>Training in quality management system (QSM) such as ISO9001:2008 and/or ISO 15189 -2012&nbsp;</li><li>Training in GLP/GCP &nbsp;</li></ol>&nbsp;<br />&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <strong>EXPERIENCE:</strong> <ol><li>Four years or above working experience in health, pharmaceutical or research institutions</li><li>At least one year of experience as QA officer (manager) in health or research institutions or as R &amp; D expert (officer) in pharmaceutical industries</li><li>Experience in document preparations such as SOPs (standard operating procedures)</li></ol>N.B. Masters Degree in clinical laboratory management &amp; quality assurance or in related fields with relevant work experience is an advantage.<br />&nbsp;<br /><strong>Other Competencies:</strong><br />4.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; High Value for Quality performance, detail oriented with good organizational traits<br />5.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Strong written &amp; verbal communication skill.<br />6.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Excellent Computer Competency including proficiency in Microsoft Word, Excel, etc<ol><li>High self-motivation and willingness to work occasional night and weekend schedules.</li><li>Know how to clinical, clinical laboratory or pharmaceutical operations is an advantage</li></ol>&nbsp;<br />Salary<br />&nbsp;<ul><li>Negotiable/attractive</li></ul>Benefits <ul><li>100% medical cost coverage at the institute</li><li>Transport service</li></ul>Required Number<br />&nbsp;<ul><li>ONE (1)</li></ul>

How to Apply

<strong><u>Note</u></strong><strong>:</strong>&nbsp; <strong>Please apply only online through <u></u></strong><br />&nbsp;<br />Dead line: April 03<br /><br />&nbsp;