Quality Assurance Specialist

1 week ago

United States Bausch + Lomb Full time

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 worldfrom 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.Quality Assurance Specialist/ Deputy Responsible PersonLocation: Warsaw, Marynarska 15 / Urzut, Aleja Katowicka 283Your responsibilties:Quality Assurance Specialist responsibilities:Supports the development and maintenance of Quality Management Systems across Bausch + Lomb Affiliates in Poland, CEE, the Balkans, Ukraine, and other applicable sites in EMEA region.Manages and monitors the effectiveness of Quality Management System processes, including but not limited to: Non-Conformances (NC), Corrective and Preventive Actions (CAPA), Change Management, and Training.Serves as the local administrator for the Compliance Wire training management system.Provides quality support within the ERP system for products (medical devices) stored at External Logistics Operators.Conducts self-inspections to ensure compliance with internal quality standards.Acts as the QA representative during internal and external audits and inspections.Participates in EMEA and global quality initiatives and projects.Deputy RP responsibilities:Acts as a back-up for the Responsible Person in pharmaceutical wholesale operations in Poland, in accordance with the requirements outlined in DPD 2.2, point 7.Releases received pharmaceutical products for distribution within the ERP system.Investigates inbound and outbound logistics discrepancies, as well as storage-related issues such as temperature excursions, physical damages, and quantity or quality deviations.Coordinates mandatory reporting to ZSMOPL (the Polish national pharmaceutical tracking system).Participates in new product launches, ensuring effective communication and compliance with GIF (Main Pharmaceutical Inspectorate).Collaborates cross-functionally with internal departments including Logistics, Order Management, IT, and Regulatory Affairs.Maintains effective cooperation with the External Logistics Operator to ensure smooth and compliant supply chain operations.Our requirements:Degree in Pharmacy.Active license to act as a Responsible Person back-up in Poland, in accordance with Polish Pharmaceutical Law and GIF requirements (Pharmaceutical Law, Article 84).Minimum of 2 years of professional experience in pharmaceutical wholesale.Experience with SAP ERP system is an advantage.Fluent in written and spoken English.Strong organizational skills with the ability to effectively prioritize tasks.Capable of working independently while managing a defined agenda.This position may be available in the following location(s):

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