QASE

Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is solely focused on making people see better to live better. The company has a 40-year track record of growth and diversification in Waterford – Ireland’s oldest city. 

From Waterford, Bausch + Lomb supplies eye health products to people across the world.

The company’s success in Waterford has been built on a great team who between them have thousands of years of experience of delivering the highest quality every time. As the facility has grown, new opportunities have been created for skilled people to join the team and take their careers to the next level in a global company with deep local roots in Waterford.

Responsibilities

- Liaise with shift management to manage the Manufacturing operation to provide the required volume output per shift which complies with all quality and regulatory requirement

- Determine appropriate lot disposition decisions on a   shift by shift basis

- Manage, review & approve any non-conformances that may occur

 - Provide quality oversight for manufacturing, including approval of validation documentation, updating PFMEAs , manage CAPA activity & continuous improvement

 - Act as the MQM interface with Operations and engineering functions.

- Disposition product as appropriate & manage any non-conformance activity

- Highlight relevant issues and participate / lead resolution

 - Understand and review Validation documentation, Change Requests, Design and Process FMEA’s

 - Participate in Quality System Continuous Improvement activities

- Ensure regulatory compliance to GMP’s of applicable medical device regulatory agencies (eg, FDA, ISO and MDD) and internal documentation.

- Provide direction to ensure product quality is maintained at all stages of the manufacturing operation.

- Additional requirements of the job will be specified by the Manufacturing Quality Manager

Requirements:

- Minimum 3 years’ experience in a regulated pharmaceutical/medical device environment

 - Manufacturing quality experience desirable

 - Full understanding of the requirements of the Regulatory Standards

 - Experience in Quality auditing an advantage

 - Experience in using Microsoft Office products

 - Experience of working in a team environment  

- Third level Qualification in Science or Engineering

 - Statistics/Six Sigma qualification an advantage

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