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Auditor Internal

4 months ago

Petaling Jaya, Malaysia Abbott Laboratories Full time

Main Purpose of the Role

This position administrates regulatory compliance activities related to the Internal Audit Program. The position is key in the facilitation/execution of the internal inspection process and ensures the Internal Audit Program across the Abbott Diagnostic

business Sites/Commercial Affiliate Sites serves to identify Quality System improvements. Independently conducts assigned audits of Suppliers and Third-Party Manufacturers (TPM's) to assess compliance to all applicable external standards and

regulations as well as Abbott Quality System requirements at a standard commensurate with regulatory external audits.

Main Responsibilities

Plans and conducts internal audits across the Abbott Diagnostic business Sites/Commercial Affiliate Sites to assess compliance to all applicable External Standards and Regulations as well as Abbott Quality System requirements.

  • Identifies compliance risks to current standards / regulations and may guide in the planning and execution of Quality System improvements.
  • Ensures compliance to Division and Corporate policies and procedures by promptly reporting non-compliance issues.
  • Support and implement an internal audit schedule for Core Diagnostics manufacturing and commercial affiliate sites.
  • Reports audit findings in a timely manner.
  • May leads projects that are cross-functional in scope, directly influences project direction and scope, champions new initiatives.
  • Maintains and demonstrates understanding of global standards, regulations and regulatory bodies.
  • The above statements are intended to describe the general nature and level of work that is being performed; other duties may be performed as assigned.

Qualifications

Education

  • Batchelors Degree in Life Science, Engineering or closely related discipline is required. A non-scientific certification with a minimum of 3 years of Medical Device experience may be considered in lieu of a degree.

Experience/Background

  • Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820; ISO 13485; IVDR; etc.
  • Trained in auditing techniques; Certified Auditor qualification or equivalent is required. Excellent written and verbal communication skills.

Minimum Skills Required
  • The incumbent will report to the Manager; Global Compliance and Auditing and will be a direct staff member. It is expected that the individual will interact with senior management and therefore requires a high level of competence; confidence and credibility. International travel is expected of up to 60%.