All Africa Leprosy Tuberculosis and rehabilitation training center (ALERT) would like to hire qualified candidates for the following post Position: Quality Assurance (QA) Officer Department: Clinical Trials & Laboratory management Job Summary
Ensuring planning, coordination, and continuous improvement of processes and methods are established to control the quality of studies conducted at the institute
Responsible for ensuring clinical, pharmacy, laboratory and data management processes are conducted in accordance with guidelines, regulations and SOPs.
Develops, performs, and manages quality assurance activities and oversees systems & study audits.
Essential Duties and Responsibilities - Organize and lead overall activities in QA unit - Prepare and/or review QA documents and SOPs - Lead and/or assist in preparing SOPs and other relevant study documents in quality study management at the clinic, laboratory and pharmacy levels. - Ensure that all processes contributing to the performance of clinical studies are conducted properly.
Develop and maintain GCP/ICH compliant processes which control the quality of work and clinical trials conducted at the clinical site
- Monitor over study databases for the quality system. - Prepare and assist in preparing annual or interim reports and quality trending reports. - Act as internal auditor for reporting the status of the quality levels of staff, systems, services/processes and study records. - Ensure that investigator, vendor, facility and system audits are conducted. - Evaluate quality events, incidents, queries, and complaints. - Document, keep up to date and communicate all related local and international clinical & laboratory quality guidelines, legislations and compliance issues. - Compile and prepare study documents & materials for submission to regulatory agencies when indicated. - Assume a lead role for the preparation, conduct, and responses to regulatory agency. - Assist/organize in providing training to the clinical & laboratory staff - Lead all activities in preparing the clinical site and laboratories for accreditation - Troubleshoot activities in clinical studies. - Communicate any critical compliance risks noted from these activities to senior management. - Perform other related duties as assigned by team leaders and director
Job Requirement
QUALIFICATIONS REQUIRED
EDUCATION:
1. Bachelors Degree or equivalent in clinical, laboratory or related Sciences
Certificate Training:
Training in quality management system (QSM) such as ISO9001:2008 and/or ISO 15189 -2012
Training in GLP/GCP
EXPERIENCE:
Four years or above working experience in health, pharmaceutical or research institutions
At least one year of experience as QA officer (manager) in health or research institutions or as R & D expert (officer) in pharmaceutical industries
Experience in document preparations such as SOPs (standard operating procedures)
N.B. Masters Degree in clinical laboratory management & quality assurance or in related fields with relevant work experience is an advantage.
Other Competencies: 4. High Value for Quality performance, detail oriented with good organizational traits 5. Strong written & verbal communication skill. 6. Excellent Computer Competency including proficiency in Microsoft Word, Excel, etc
High self-motivation and willingness to work occasional night and weekend schedules.
Know how to clinical, clinical laboratory or pharmaceutical operations is an advantage