**ABOUT ABBOTT** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **WORKING AT ABBOTT** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: + Career development with an international company where you can grow the career you dream of. + A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. + A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. **ROLES & RESPONSIBILITIES** **1, Summary:** Quality System implementation at the local EPD Commercial site and assures that quality related matters associated with products commercially distributed including those from Local TPM conform to current Good Manufacturing Practices (cGMP), Abbott Quality standards, and other applicable regulatory standards. **2, Core job responsibilities:** 2.1. Quality System: Join the development and maintanance of QMS to manage the quality activities in the Vietnam affiliate and ensure the safety, quality and benefit of the products that were imported and distributed in Vietnam. Documentation coordinator: + Manage the document system of VN affiliate, which includes but not limited to Quality Manual, SOPs, forms, training material, logbooks, layouts... + Document distribution and archive, ensure the correct documents is avaialble at cross functional teams and obsolete versions are kept safe during the document life cycle, executing the document destruction as per Abbott policy. + Working as DARIUS coordinator, support requests for creation or changes to documents, processing change requests in the DARIUS electronic document management system, control the effective status of documents. Handle queries or raise tickets related to DARIUS + Monitor the periodic review of all GMP documents at VN affiliate. + Monitor all AQ/ EQD/ COMM documentation and system changes to ensure they are implemented at VN affiliate in correlation (prior to or at the same time as) with the Effective Date of the corporate/ global/ regional document by initiating the implementation review process, track activities as per action plan and update the to the management when required. Training coordinator: + Monitor the training program at Vietnam affiliate, collaborate with cross functional teams across affiliate for GxP training and ensure the training metric is tracked as expectation. + Create courses, modules, generate monthly reports for reconciliation of overdue training. + Handle queries or raise tickets related to ISOtrain Change control coordinator + Processing change control in SolTRAQs system with appropriate approvers, track action plan execution and completion of action as due, request extension for CC that cannot be completed on time, update extended date for action plan extension requests. + Ensure all requirements and effectiveness criteria are met before closing CC. + Handle queries or raise tickets related to SolTRAQs. Metric and management review: + Arrange the periodic meeting (minimum quarterly) with leadshipteam at Vietnam affiliate, consolidate the deck and track the Minute of Meeting. + Follow up the quality metrics at all relevant departments, including adherence to set targets and coordinator to develop the action in case the quality metric excursion. Implementation of regulations review. + Lead to assess the new local GxP regulation of regulation changes at affiliate to ensure the strategic alignment is indentified on time. + Initiate and follow status of change control during impact assessment after strategic alignment. Reports the outcome of mornitoring in the management review. Quality Audit Program and Product action + Coordinating the Internal Audit/self-inspection at Commercial Affiliate to ensure effectiveness of Quality System Implementation including schedule, audit arrangment, CAPA monitoring and trending. + Coordinating the audit preparation for audits from external of Affiliate to ensure the audit results meet expectation + Coordinating the meetings for product action with distributors, relevant teams, track the record, prepare required reports and do the reconciliation + Support the mock recall 2.2. FIE warehouse: Join in preparing SOPs for the document system of warehouse (compliance and quality system part) when when the warehouse is set up, ensure the document system meet GSP requirements, Abbott policy. Verify the GxP records related to warehouse quality sytsems to ensure its compliance with Data integrity and GSP requirement Support the audit readiness about: + Arrange and monitor the internal audits/ gemba at new warehouse to indentify the areas need to improve and define actions on time. + Backroom management for DAV audit to ensure the audit is excuted smoothly, front room SME in DAV audit for relevant areas. 2.3. Identify continuous improvement opportunities on error, action, root cause analysis, corrective action, preventive action, general improvement opportunities at affiliates and related distributors, warehouse. 2.4. Other work/function/ job rotation that may be assigned. **MINIMUM BACKGROUND/ EXPERIENCE REQUIRED** **Work Experience** : + Pharmacist at least 3 years’ experience in Pharmaceutical or medical device (or related industry) QA/Regulatory + Experience with FIE warehouse or QA manufacturing site **Core Skill Requirement** + Adaptability, Initiative, Integrity + Planning and Organizing + Ability to prioritize + Ability to use Quality Tools and Quality IT systems such as benchmarking, gap analysis, pareto analysis, fish- bone diagrams, and process mapping for fact base decisions making, ISOTrain, SolTRAQs... + Project management and troubleshooting skills + Fluent in English. Ability to communicate both written and orally, to all levels of management and across different cultural backgrounds + Knowledge of local regulations for quality systems and compliance + Ability to identify problems, and initiate corrective actions and preventative actions + Sound decision-making skills contributing to high levels of competence, confidence and credibility are required + Well-developed interpersonal, communication and negotiation skills + Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.) + Change management + Strong regulatory and GxP compliance An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com