AbbVie Auditor, QA Compliance in Santry, Ireland

Description:

AbbVie employees work every day to discover and address many of the world's most pressing health challenges. Our work helps people live better lives. When you have patients depending on your solutions, you look for the best people to be part of the team. We are always looking for talented people to join our team and, when we find them, we make it our business to treat them well.

We are currently sourcing aQA Compliance Auditorto join our global QA Audit & Compliance team. In this role, you will perform evaluations for compliance with US and foreign regulation requirements (minimally may include the Americas, Asia, Africa, Australia, European Middle East regions) and provide constructive evaluation of quality related systems for suppliers that provide materials, services and products to AbbVie. Suppliers can include API suppliers, contract labs, excipient suppliers, commodity suppliers, devices, specialty pharmacies, logistic providers and third party manufacturers. Their execution in the area of 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.

Major Responsibilities:

  • 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 at the supplier.
  • The position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement and objectivity.
  • Participate in strategic initiatives to improve compliance to regulatory requirements and standards.

Qualifications:

  • Education & Experience: *

    • 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.
    • 2 years in Quality Assurance with some project management experience in the pharmaceutical, medical device/nutritional or related industry. One year in compliance/auditing is required. Total combined experience expected to be at least 6 years.
    • ASQ certification desired, not required.
    • Fluent in English.

    This role can be based anywhere in Europe and will involve 50% travel internationally.

Job Classification: Experienced
Job: QUALITY ASSURANCE
Primary Location: Ireland-Leinster-Santry
Organization: Operations
Schedule: Full-time
Shift: Day
Travel: Yes, 50 % of the Time
Req ID: 1706424