Shanghai, CHN
10 days ago
Quality Auditor
**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. 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
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