Senior Quality Systems Specialist

Bausch + Lomb; Waterford; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

Bausch + Lomb in Ireland invites a Senior Quality Systems Engineer to support the Quality Systems Manager and maintain the supplier management program in alignment with GMP requirements.

You will lead supplier audits, manage CAPA processes, and drive continuous improvement across quality systems while collaborating with QA, engineering, and HR teams to ensure regulatory compliance and robust documentation practices.

Qualifikationen

• Full understanding of the requirements of the Regulatory Standards.
• Strong communication skills and ability to influence others.
• Self-starter with the ability to prioritise and work on own initiative.
• High attention to detail and thorough documentation habits.
• Experience with quality auditing and supplier auditing.

Aufgaben

• Maintain and improve the Supplier Management system to ensure GMP compliance.
• Manage the Supplier Audit Schedule and ensure it remains up to date.
• Oversee incoming inspection and site MRB processes.
• Lead CAPA investigations and drive corrective actions with suppliers.
• Generate supplier metrics for management reviews and dashboards.
• Support internal audits and regulatory bodies with accurate records.

Kenntnisse

Quality systems

Supplier auditing

GMP compliance

Regulatory standards

Excellent communication

Ausbildung

Third level Qualification in science or Engineering

Database management experience

Tools

Documentum

Catsweb

Kintana

Jobbeschreibung

Bausch + Lomb (NYSE/TSX: BLCO) 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 is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of 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.

Overview

The Senior Quality Systems Engineer is instrumental in providing support to the Quality systems manager maintaining the site supplier management system, continuous improvement projects and ensuring compliance to all quality standards and adherence to GMP requirements.

Objectives

• To set up and maintain in a compliant state, the Supplier Quality Programme
• To maintain the Supplier audit schedule
• To aid in the complaints process.
• To manage the administration and tracking for applicable Quality Systems.
• To liaise with external auditors and regulatory bodies.
• To provide support to the Quality Systems Manager in setup, maintenance and continuous improvement of the Quality System.

Key Activities/responsibilities

• Manage and maintain the Supplier Management system continually looking for areas of improvements
• Manage and maintain the Supplier Audit Schedule and ensure in compliance
• Manage incoming inspection
• Complete Site MRB’s
• Deal with Supplier issues and ensure effective corrective action plans for supplier related issues
• Maintain Supplier metrics for Quality Management reviews
• To develop systems for the control and trending of corrective and preventative action.
• Participate in the internal audit Programme.
• SIR management, including investigations, NON conformance and CAPA management.
• Aid in the Quality Metric Management systems.
• Populate and issue Monthly Supplier Metrics for the plant.
• Preparation for the Yearly Management review.
• Participate in the Plant Quality Plan.
• Continuous Improvement projects.
• Risk Management Process.
• Site GMP training.
• Change Management Activities.
• Global Gap analysis review.Maintain good documentation practices for Work instructions, SOP’s and Forms.
• Additional requirements of the job will be specified by the Quality Systems Development Manager.

Key Relationships

• Production Colleagues
• Production managers
• Suppliers
• Maintenance technicians
• Warehouse Colleagues
• Process excellence Department
• Training Department
• QA Department
• Engineering Department
• HR Department
• GPS

Qualifications/training

• Full understanding of the requirements of the Regulatory Standards
• Good Communication skills
• The ability to motivate and influence people
• Self-Starter, highly motivated with the ability to prioritize
• Ability to work on own initiative
• High attention to detail
• Documentum, Catsweb, Kintana and other Quality systems
• Third level Qualification in science or Engineering
• Experience in Quality auditing and Supplier auditing
• Experience in Database Management an advantage
• Experience in using Microsoft office products
• Experience of team working

Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.