About Bausch + Lomb Ireland Limited
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 from the moment of birth through every phase of life.
Our Mission
We help you see better, so you can live better.
Comprehensive Portfolio
We offer over 400 products that are fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives.
Iconic Brand
Our brand is built on deep trust and loyalty with our customers, established over our 170-year history.
We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe.
We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
Quality Assurance Manager Role
Key Responsibilities:
* Manage the Quality Management System (QMS) to ensure it is fit for purpose and make changes as necessary.
* Approve 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 Ireland Limited as MAH.
* Manage communications with and represent Bausch + Lomb Ireland Limited in front of HPRA.
* Provide QA expertise to Bausch + Lomb Ireland Limited and manage any Quality issues that arise to closure.
* Support HPRA inspections of Bausch + Lomb Ireland Limited and prepare written responses to inspections.
* Support Bausch + Lomb internal compliance audits of Bausch + Lomb Ireland Limited operations.
* Prepare and approve HPRA variations.
* Provide QA oversight and expertise for New Product Introductions.
* Review and approve Non-Conformances (NC), 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.
* Review, and where appropriate, preparation and regular update of technical agreements with licensees and 3rd party contractors.
* Regular presentation and review of intercompany Quality service provider performance against measures relating to the Bausch + Lomb Ireland Limited Quality Objectives at periodically held Quality Operations meetings.
* Periodic review of QMS and operational procedures for regulatory compliance through internal audit system.
* Scheduling periodic Quality Operations management review meetings with third parties, annual Quality Management Review meetings, and preparing the agenda and minutes for both meetings.
* Attending the annual Quality Management Review meeting and participating in the review of the Bausch + Lomb Ireland Limited Quality and Regulatory Compliance Policy and Objectives for continuing suitability.
* Implementation of the Self Inspection/Internal Quality Audit program.
* Overall responsibility for reporting and investigation of non-conformances and identification of CAPAs to ensure continuous improvement of the QMS and operational procedures.
* Escalation of issues as appropriate.
Requirements:
* BSc (Hons) in Science or equivalent.
* QP/RP qualification. QP desirable.
* Thorough working knowledge of GMDPs and regulatory expectations for medicinal products and medical devices.
* Minimum of 5 years of experience working in Quality Assurance in the Health Care Industry.
* Ability to work on their own initiative and within teams.
* Ability to analyse complex problems and identify solutions.
* Strong communication and organizational skills.
* Leadership skills.
* Excellent ability to deliver results, with strong interpersonal and influencing skills.
* Ability to build relationships internally and externally.
* Trained auditor.
* Available to travel if required to fulfill role.
Benefits
Work From Home