Quality Assurance Manager

3 days ago


Dublin, Dublin City, Ireland Bausch & Lomb GmbH Full time
Job Description

Bausch & Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world.

We are seeking a highly skilled Quality Assurance Manager to join our team in Dublin. As a key member of our Quality Assurance department, you will be responsible for managing and maintaining our Quality Management System (QMS) and ensuring that it is fit for purpose.

Main Responsibilities:

  • Manage the QMS, including approving SOPs and quality system documents.
  • Maintain quality processes in support of Bausch & Lomb Ireland Limited authorizations.
  • Ensure processes are maintained in support of Bausch & Lomb as Marketing Authorization Holder (MAH).
  • Manage communications with and represent Bausch & Lomb in front of the Health Products Regulatory Authority (HPRA).
  • Provide QA expertise to Bausch & Lomb and manage any quality issues that arise to closure.
  • Support HPRA inspections of Bausch & Lomb and prepare written responses to inspections.
  • Support internal compliance audits of Bausch & Lomb operations.
  • Prepare and approve HPRA variations.
  • Provide QA oversight and expertise for new product introductions.
  • Review and approve non-conformances, CAPA, change controls, and complaints.
  • Ensure annual review of supplier and customer bona fides to verify compliance with guidelines on good distribution practice.
  • Ensure batch record review to verify compliance with GMP and market authorization prior to batch release.


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