Auditor, QA Compliance

4 weeks ago

hyderabad, India AbbVie Full time
Job Description

The function of Audit and Compliance Co-Auditor is to assist and support the Internal Audit and Compliance Team in performing evaluations for compliance with US and foreign regulation requirements (minimally may include the Americas, Asia, Africa, Australia, European Middle East regions). The Co-Auditor will also work with the Internal audit team to 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.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

  • With guidance from another member of the Internal Audit 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.

Qualifications

Qualifications

List required and preferred qualifications (up to 10). Include education, skills and 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 (Good Manufacturing Practices) 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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