Quality Assurance Specialist/Deputy Responsible Person

Quality Assurance Specialist/Deputy Responsible Person

Bausch & Lomb

Warsaw, Poland

Your 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.