Abbott QA Auditor in Shanghai, China

1.POSITION: QA Auditor

2.DIVISION: EPD

3.FUNCTION: Quality Assurance

4.REPORTS TO: QA Manager

5.DIRECT REPORTS: None

6.EDUCATION REQUIREMENT:

Bachelor Degree or equivalent level of education at a relevant scientific discipline (Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific)

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7.RESPONSIBILITIES:

Primary Job Function

The role of the EPD Regional QA Auditor function is to manage on-site audits and Quality Questionnaires, related to Suppliers and Third Party Manufacturers that fall under the responsibility of EPD LATAM Regional QA.

The scope is Suppliers and Third Party Manufacturers that provide materials, services and products to EPD. Suppliers can include API suppliers, contract labs, excipient suppliers, commodity suppliers and third party manufacturers who provide intermediate/final products to EPD.

Core Job Responsibilities

List the primary tasks and/or activities this job performs on an ongoing basis.

  • Manage on site audit for supplier and Third Party Manufacturers that provided materials/services to the region, but located worldwide.

  • 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 that provided materials/services to the region, but located worldwide.

  • 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 LATAM regional senior 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.

8.REQUIREMENTS:

  • Language Skills: Fluent in English both oral and written

  • Computer Skills: Working knowledge, especially good at Excel and PowerPoint

  • Other Special requirement:

  • Thorough understanding on the healthcare industry(pharmaceutical and medical device markets) is a plus

  • Autonomy/Independence, Assertiveness; a polished professional presence is essential

  • Strong sense of responsibility, self-motivated, and well organized

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