Quality Auditor job opportunity at Abbott.

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DatePosted 30+ Days Ago bot
Abbott Quality Auditor
Experience: 8-years
Pattern: full-time
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loacation China > Shanghai : 388 W. Nanjing Road, Ciros Plaza, China
loacation China > Shangh..........China

      JOB DESCRIPTION: Core Job Responsibilities: Manage on-site audits for supplier and Third-party Manufacturers that provide materials/services to EPD.. All activities required to plan, prepare for, conduct, report and close the assigned audits. Ensure that all audit related information is documented into the Audit Tracking system in a timely manner. Manage Quality Questionnaire for supplies and Third-Party Manufacturers Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close for supplier and TPMs evaluated. Timely information on the audits to management and stakeholders. Escalation of any critical findings or negative audit outcomes to EPD Auditing management, in line with the applicable policy and procedures. Reviewing any Quality Questionnaires returned by the Suppliers/TPMs and resolve any issues. Read and extract developing regulations and trends from available sources to provide recent perspectives during audits. Ensure a proactive determination of regulatory, compliance and quality issues and integrate them into audits/assessments on a priority basis.  Provide support to EPD plants in the timely resolution of issues related to suppliers.  Discuss with and agree with the supplier a timely implementation of corrective and preventive actions, as needed to prevent recurrence Minimum Education: Bachelor’s degree or equivalent level of education at a relevant scientific discipline (Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific), or industry experience with sufficient exposure to pharmaceutical or related industries. Minimum Experience/Training Required: At least 8 years in the Pharmaceutical/Healthcare Industry and/or Government Regulatory Agency; and at least 3 years of Auditing experience related to GMP, GDP or ISO for Pharma, Medical Devices and Nutritional product types Knowledge and understanding of the ICH and other relevant technical guidelines, as well as GMP guidelines. Understanding of the WHO and other applicable regional and local regulations Good Communication skills Advanced written and verbal skills in Business English Competencies required: adaptability, initiative, integrity, planning & organizing, information gathering, analytical thinking, interpersonal understanding, cultural sensitivity, ethical behavior, independence, decisiveness Availability for traveling.       The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Operations Quality       DIVISION: EPD Established Pharma          LOCATION: China > Shanghai : 388 W. Nanjing Road, Ciros Plaza       ADDITIONAL LOCATIONS:       WORK SHIFT: Standard       TRAVEL: Not specified       MEDICAL SURVEILLANCE: Not Applicable       SIGNIFICANT WORK ACTIVITIES: Not Applicable                  

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