Auditor Internal

5 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%.


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