Quality Auditor
Abbott
**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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