Superviseur de production IgIV

Job Summary Superviseur de production IgIV - Production Supervisor IGIV at Grifols Reporting to the Manufacturing Director, the Supervisor leads the daily manufacturing shift activities in the IGIV Purification area of the Grifols Canada Therapeutics facility. The role ensures quality, safety, delivery and productivity objectives are met, and oversees all assigned team members. Key Duties And Responsibilities Lead and direct the daily manufacturing shift activities, ensuring all tasks are assigned and followed up throughout the shift. Ensure notifications (quality or preventative maintenance) are issued promptly and investigations are completed in a timely manner. Ensure all manufacturing schedules, products and materials are delivered. Train IGIV Purification personnel on process activities, including safety requirements and cGMP requirements; identify and close technical and non‑technical development gaps; review safety cases and implement corrective actions. Develop, train and monitor personnel to ensure products are manufactured in accordance with regulatory requirements, GCT procedures and GxP regulations. Ensure compliance with site operating procedures and policies, including health and safety protocols, and all federal health authority regulations related to IGIV Purification manufacturing operations. Understand and adhere to Good Documentation Practices (GDP). Coordinate and draft reviews of batch‑related documents, including batch records and SOPs. Execute quality management system assignments (CAPA, change control, standard operating procedures, etc.) and close them on time. Ensure equipment is functioning properly; request and coordinate repairs or modifications. Resolve operational and equipment issues and make recommendations; coordinate emergency repairs, changes and preventative maintenance activities with the utility team. Coordinate manufacturing activities with other departments, working closely with quality control, materials management, quality assurance, validation, etc. Qualifications CEGEP or technical degree mandatory; BS degree in Science, Engineering or related field preferred. 1 to 3 years of manufacturing leadership/supervisor experience in a cGMP biopharmaceutical environment. Good understanding of the operating principles of most process equipment; strong knowledge of the technical and scientific principles associated with aseptic processing. Good knowledge of automated control systems. Good knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations. Comprehensive knowledge of aseptic operations, statistics, equipment design, process control, scale‑up, pharmaceutical processes and equipment validations. Ability to troubleshoot and maintain manufacturing systems, equipment and processes. Ability to dress aseptically for cleanroom operations. Ability to react quickly to understand and solve problems. Excellent communication and documentation skills, organizational and troubleshooting skills. Ability to accurately read, understand and follow company SOPs and guidelines. Proficient writing and computer skills; advanced proficiency in Microsoft Word, Excel, PowerPoint and Project. Bilingual in French and English (spoken and written); mastery of English required for communication with sites outside Quebec and Canada. Location Montreal, Quebec, Canada Additional Information Seniority level: Mid‑Senior level. Employment type: Full‑time. Job function: Management and Manufacturing. Industries: Pharmaceutical Manufacturing and Medical Equipment Manufacturing. #J-18808-Ljbffr