Auditor, QA Compliance

4 weeks ago

Dublin, Ireland AbbVie Full time
Job Description

We are looking for an experienced Auditor, QA Compliance to join our Global Supplier Audit (EU region) team at AbbVie, based in Ireland. This role assists and supports the Supplier Audit Team in performing evaluations for compliance with US/EU and foreign regulation requirements (minimally may include the Americas, Asia, Africa, Australia, European Middle East regions).

The suppliers that you deal with can include API suppliers, contract labs, excipient suppliers, commodity suppliers, medical devices, logistic providers and third party manufacturers.

A snapshot of your key responsibilities as Auditor, QA Compliance would be:

  • Travel to our supplier sites and with guidance from the Audit Management Team, assess compliance of systems, facilities, and procedures per applicable regulations through audits and assessments of our suppliers, assuring compliance to regulatory requirements and AbbVie specifications.
  • Provide feedback in the form of audit observations, and review corrective actions to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained by the supplier.
  • Support strategic initiatives to improve compliance to regulatory requirements and standards.
  • Audit suppliers to ensure that their GMP compliance and quality assures that activities are performed and documented in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements intended to assure the quality, effectiveness and safety of our products.

Qualifications

  • Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 4 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries.
  • Must have a technical background and requires understanding of the audit process and knowledge of worldwide requirements related to GMP regulations for quality systems and compliance.
  • Must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support and service and understand the principles of quality management.
  • The individual must have excellent oral/written communications skills.
  • Personal skills needed include interpersonal skills, tact, open mindedness, maturity, tenacity, self-reliance, organizational/administrative skills and sound judgment. Effective communication skills are essential with an ability to work effectively outside of the company and across functional and technical areas
  • One year in Quality Assurance with some project management experience in the pharmaceutical, medical device or related industry. One year in compliance auditing is required. Total combined experience expected to be at least two years.
  • Fluent in English. Including reading, writing and verbal communication.


Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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