Automation/ QA Engineer

AbbVie QA Compliance Manager

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Our employees work every day to discover and address many of the world's most pressing health challenges. When you have patients depending on your solutions, you look for the best people to be part of the team.

We are now recruiting a QA Compliance Manager to join our join our high performing Quality team in our Carrigtwohill site in Cork. In this management role, you will be responsible for the quality assurance compliance activities in the Cork Site. You will also lead the implementation and maintenance of quality assurance activities in compliance with the current GMP regulations.
Are you intrigued? Do you want to learn more?

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

  • Managing all QA Compliance Activities including the Site Document Controller / QA Administrator, and QA Compliance Specialists, project related resources as required.
  • Completing the Annual Appraisals of the QA staff.
  • Partaking of department budget management
  • Management of the electronic documentation system.
  • Ensure appropriate QA Reviews / Approvals of GMP documentation eg, SOPs, reports, methods, specifications, validation protocols etc.
  • Management of the Archive System of QA documentation.
  • Preparation of the Site for Regulatory Inspections and Internal Compliance QA Audits and management of same.
  • Preparing and reviewing QA department reports and metrics
  • Site Business Administrator for SolTRAQS – Exception Reports, CAPA, Change Requests, Planned Deviations, AudiQ and Customer Complaints.
  • Establish the requirements for conducting and documenting Site Management Reviews so as to ensure the suitability and effectiveness of the quality system.
  • Management and delivery of all QA Activities related to New Product Introduction. This includes ensuring QA Compliance in all phases of the NPI Projects – Feasibility, Demonstration and Validation and QP release as required.
  • Degree in Science or related discipline
  • Education to meet the requirements for position of Qualified Person as defined in Article 49 Directive 2001/82/EC.
  • Minimum 5 years in Pharmaceutical Environment
  • Experience to requirements for position of Qualified Person as defined in EU GMP volume 4 and annex 16.
  • Experience of GMP Auditing and Documentation