Quality Assurance Specialist – Levant
Job Description
<strong>AbbVie Quality Management System Implementation <br><br></strong>The Affiliate QA Specialist will provide quality assurance support for quality system requirements associated with pharmaceutical products, medical devices, combination products, biologics, and Aesthetics products.<br><br><ul><li>Specific areas of support include Product Quality, Process Performance, Documentation Management, CAPA, Change Management, and Risk Management. </li><li>This position ensures that all product, process, or system related quality activities supporting the business at the affiliate from receipt of final product through distribution are in compliance with corporate, governmental, and local regulations and requirements.</li><li>Supports assessments to determine compliance to corporate processes, procedures, and regulations to identify potential gaps and mitigate and implement improvements. </li><li>Delivers expected performance to maintain the affiliate KPIs. Ensure metrics and KPIs are met. Support in evaluation, and in analyzing trending quality indicators, data and performance metrics. </li><li>Proactively and continuously aspires to implement AbbVie QMS according to the company guidelines and compliance policies.</li><li>Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems. </li><li>Assist project teams in planning, preparation, review, and approval of quality documentation.<br><br></li></ul><strong>Supplier and Distributor management<br><br></strong><ul><li>Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans. </li><li>Support carrying out a quality self-inspection program within the affiliate.</li><li>Support the Quality management of supplier qualification program including performance monitoring for key suppliers and update of Quality Technical Agreements.<br><br></li></ul><strong>Quality Planning and Management<br><br></strong><ul><li>Support in the Management Review and Quality Planning processes at the affiliate.</li><li>Represent Affiliate QA Manager in the tasks delegated to them by the QA Manager. Support activities related to quality events (significant event management; quality defects, security events and recalls) in the affiliate. </li><li>Coordinate and investigate quality events such as deviations, non-conformances, product complaints and corresponding action plans including decisions. </li><li>Support in general quality-related operational activities for Levant and Gulf: release letter readiness, questionnaires and certificates review, suppliers’ licenses and certifications management, training documentation management. <br><br></li></ul><strong>Quality Knowledge, Development and Partnership <br><br></strong><ul><li>Work well with manager’s guidance to complete tactical objectives while able to manage own time effectively.</li><li>Develop a thorough action plan focused on key quality pillars to maintain the affiliate KPIs and QA index score in partnership with affiliate key stakeholders.<br><br></li></ul><strong>Skills And Competencies<br><br></strong><ul><li>Ability to work in both, teams setting and independently. Strong negotiation, motivational, interpersonal and relationship building skills. </li><li>Ability to think strategically.</li><li>Ability to make operational and business decisions with manager directions.</li><li>Time management, prioritization and attention to details.</li><li>Ability to work under pressure and meet tight deadlines.</li><li>Operates effectively in a matrix environment.</li><li>Enthusiastic and ability to learn and improve.</li><li>Great sense of ethics and integrity.<br><br></li></ul><strong>Qualifications<br><br></strong><ul><li>Technical knowledge preferred in the following areas: Quality, Regulatory and Product storage and distribution Operations. </li><li>Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred.</li><li>Strong verbal and written communication skills.</li><li>Proficiency in English. Proficiency in Arabic is a plus.</li><li>Proficient Computer skills. <br><br></li></ul><strong>Studies And Experience<br><br></strong><ul><li>Bachelor’s degree in pharmacy, Biology, Microbiology, Engineering or other technical/scientific area.</li><li>3+ years’ experience in pharmaceutical settings. Experience in quality assurance, quality oversight or relevant experience is a plus. <br><br></li></ul>AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
