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QC Chemist
2 months ago
Location: IE - Waterford, Ireland - All, IE
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.
¨ Sampling and testing of raw material, in-process materials and finished products.
¨ Lead analyst at a technical level in out of specification investigation and non-conformance management.
¨ Project lead in lab process validations, cleaning validations and equipment qualification.
¨ Participate in site validations for the process.
¨ Ensure that the laboratory is compliant to regulatory systems.
¨ Sampling and testing of materials, utilities and environment.
¨ Ensure all operations are conducted in accordance with GMP’s and good scientific principles.
¨ Manage documentation and equipment maintenance systems within the laboratory.
¨ Review chemical analysis data of raw materials, in process and finish products and assess the results and action as appropriate.
¨ Manage out of specifications, out of trends and any laboratory non-conformances.
¨ Control and management of stability activities including the monitoring of stability chambers.
¨ Provide product support by completing line clearances.
¨ Involved in updating documents within the site.
Principal Responsibilities
¨ Sampling and testing of raw material, in-process materials and finished products.
¨ Lead analyst at a technical level in out of specification investigation and non-conformance management.
¨ Project lead in lab process validations, cleaning validations and equipment qualification.
¨ Participate in site validations for the process.
¨ Ensure that the laboratory is compliant to regulatory systems.
¨ Sampling and testing of materials, utilities and environment.
¨ Ensure all operations are conducted in accordance with GMP’s and good scientific principles.
¨ Manage documentation and equipment maintenance systems within the laboratory.
¨ Review chemical analysis data of raw materials, in process and finish products and assess the results and action as appropriate.
¨ Manage out of specifications, out of trends and any laboratory non-conformances.
¨ Control and management of stability activities including the monitoring of stability chambers.
¨ Provide product support by completing line clearances.
¨ Involved in updating documents within the site.
Support quality aspects of materials management including supplier approval, supplier complaints and specification
Desirable - Degree in Chemistry with 5 years’ experience in a laboratory environment
¨ Minimum 1 to 2 years’ experience in a regulated pharmaceutical/medical device environment desirable
¨ Experience of method validation and method transfer.
¨ Familiarity with OOS management required.
¨ Validation experience within a laboratory.
¨ Experience in the use of HPLC, GC, FTIR, UV, TOC etc. as well as classical wet chemistry analyses.
¨ Full understanding of the requirements of the Regulatory Standards
¨ Self-starter, highly motivated with the ability to prioritize
¨ Ability to work on own initiative
¨ High attention to detail
¨ Experience in using Microsoft Office products
¨ Experience of team work
Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.
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