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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.
Responsibilities:
1. Sampling and testing of raw material, in-process materials and finished products.
2. Lead analyst at a technical level in out of specification investigation and non-conformance management.
3. Project lead in lab process validations, cleaning validations and equipment qualification.
4. Participate in site validations for the process.
5. Ensure that the laboratory is compliant with regulatory systems.
6. Sampling and testing of materials, utilities and environment.
7. Ensure all operations are conducted in accordance with GMPs and good scientific principles.
8. Manage documentation and equipment maintenance systems within the laboratory.
9. Review chemical analysis data of raw materials, in-process and finished products, and assess results and actions as appropriate.
10. Manage out-of-specifications, out-of-trends, and laboratory non-conformances.
11. Control and manage stability activities, including monitoring of stability chambers.
12. Provide product support by completing line clearances.
13. Update documents within the site as needed.
14. Support quality aspects of materials management, including supplier approval, supplier complaints, and specification management.
Requirements:
- 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 using 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 teamwork.
Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.
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