Job Description

JOB DESCRIPTION:Main Purpose of the RoleThis 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 Diagnosticbusiness 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 andregulations as well as Abbott Quality System requirements at a standard commensurate with regulatory external audits.Main ResponsibilitiesPlans 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.

QualificationsEducation

• 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%.

The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Operations QualityDIVISION: CRLB Core LabLOCATION: Malaysia
Selangor : Imazium, No. 8, Jalan SS 21/37ADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Yes, 75 % of the TimeMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott