Tech Transfer Technician

hace 1 mes


Azuqueca de Henares, Guadalajara, España Grupo Crit A tiempo completo

Do you have experience in supervising, preparing, and implementing protocols/reports for technology transfers? Are you looking for a new professional challenge?At Grupo Crit, we're looking for youGlobal responsabilitiesMonitor, prepare and implement protocols/reports for technology transfers, manufacturing guides and provisioning orders, batches registration, industrial lots, working guidelines, documentation and reports and Standard Operational Procedures for Transfer; according to GMP regulations, SOPs, the Pharmacopeia of the various world regions and the guidelines of the manager; in order to ensure the correct execution and updating of the processes at an industrial level.

The position involves coordinating and overseeing various aspects of product development and manufacturing within the pharmaceutical industry:

Production Scaling:
Supervise the transition of new development products from pilot to industrial scale, in collaboration with Formulation Development and Production teams

Product Scaling:
Manage the pilot and industrial scaling-up of developed products

Formula and Process Improvement:
Coordinate improvements in formulas or processes for existing products

Manufacturing Issue ResolutionCustomer Collaboration:
Liaise with internal and external customers to address product transfer requirements

Regulatory Compliance:
Manage documentation for pharmaceutical registration, ensuring compliance with governmental and legislative requirements

Batch Monitoring:
Monitor batch production and registration processes, analyzing parameters and results, and preparing reports for Production and Quality Assurance departments

Technology TransferProcedure DevelopmentQuality Assurance:
Open and close change controls, deviations, or investigations as needed, ensuring compliance with quality standards

Interdepartmental Collaboration:
Work with other departments to address project-related tasks promptly and effectively.

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