11 days old

TPM QA Product Manager

Abbott
Dublin, Dublin D01

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

PURPOSE OF THE JOB

To manage the quality related activities at a number of Third Party Manufacturer’s (TPM’s) and/or suppliers producing product  on behalf of Abbott, to ensure safe, efficacious and quality product can be supplied in accordance to regulatory and business requirements.

MAJOR RESPONSIBILITIES

  • Manage TPM’s and/or Suppliers as assigned from a Quality perspective.
  • Manage all Quality System activities associated with the role, including:
  • Develop and maintain Quality/Technical Agreements to align with legal contracts and regulatory requirements.
  • Management of high impact exception events and CAPA ensuring events are appropriately assessed for impact to Abbott and documented.
  • Review and approval of TPM Product Quality Reviews to ensure accuracy and completeness and management of actions to address any identified trends.
  • Review and approval of complaints arising from TPM/Supplier manufactured product and follow-up on complaint trend investigations for non-medical and medical (adverse events) complaints.
  • Management of all changes at TPMs/Suppliers which have a quality or regulatory impact, ensuring timely communication & implementation of changes in line with regulatory requirements.
  • Maintain a Quality Management Review program and Quality Performance Measurement for TPMs / Suppliers, that identify and address quality, operational, and organizational issues.
  • Participate on QA cross-functional teams to support TPMs, including active participation in Business Management Reviews or Workstreams, as necessary.
  • Visit TPMs &/or supplier locations routinely to build and maintain expertise with products and manufacturing processes building a close working relation with the TPM &/or supplier
  • Provide support to Abbott management through the Significant Event and Management Review process to ensure relevant information is provided for events impacting assigned TPM/Suppliers.

    EDUCATION & COMPETENCIES:

Categories

Posted: 2020-05-20 Expires: 2020-06-21

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

TPM QA Product Manager

Abbott
Dublin, Dublin D01

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast