Production Supervisor leading evening protein-filling operations at Grifols, a global healthcare manufacturer. Ensuring cGMP compliance, quality, safety, delivery, productivity, and team performance.
Responsibilities
Lead and direct daily manufacturing shift activities in the Filling area
Assign tasks and follow up on progress throughout the shift
Ensure quality and preventive-maintenance notifications are issued and investigated promptly
Ensure manufacturing schedules, products, and materials are delivered
Train, develop, and monitor Filling personnel on process, safety, cGMP, regulatory, and GXP requirements
Identify development gaps and implement plans and targets
Review safety cases and implement corrective actions
Ensure compliance with site procedures, health and safety protocols, and federal health authority regulations
Adhere to Good Documentation Practices
Coordinate and draft reviews of batch records and SOPs
Execute quality management system assignments, including CAPA and change control, to close on time
Ensure equipment operates properly and coordinate repairs, modifications, emergency work, and preventive maintenance
Resolve operational and equipment issues and make recommendations
Coordinate manufacturing activities with Quality Control, Materials Management, Quality Assurance, Validation, and other departments
Requirements
CEGEP or technical degree mandatory
Bachelor's degree in Science, Engineering, or related field preferred
1 to 3 years of manufacturing leadership/supervisor experience in a cGMP biopharmaceutical environment
Previous experience in biologics protein filling manufacturing is an asset
Good understanding of operating principles of process equipment
Strong knowledge of technical and scientific principles associated with aseptic processing
Knowledge of automated control systems
Knowledge of cGMP, OSHA, EPA, and FDA facility requirements and regulations
Knowledge of aseptic operations, statistics, equipment design, process control, process scale-up, aseptic pharmaceutical processes, and equipment validation
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, documentation, organizational, and troubleshooting skills
Ability to accurately read, understand, and follow company SOPs and guidelines
Proficiency in Microsoft Word, Excel, PowerPoint, and Project
Bilingualism in spoken and written French and English
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