Tech Transfer Technician
hace 1 semana
Descripción:
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 you
Global responsabilities
Monitor, 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.
- 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 scalingup of developed products.
- Formula and
Process Improvement:
Coordinate improvements in formulas or processes for existing products.
- Manufacturing Issue Resolution
- Customer 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 Transfer
- Procedure Development
- Quality Assurance: Open and close change controls, deviations, or investigations as needed, ensuring compliance with quality standards.
- Interdepartmental Collaboration: Work with other departments to address projectrelated tasks promptly and effectively.
Requisitos:
Requirements:
Education:
Degree in Pharmacy. Master's Degree in the pharmaceutical field
Languages:
Fluent Spanish and English, knowledge of other languages will be an asset.
Experience (years/area): +3 years of experience in a similar position, in formulation, production o tech transfer in the pharma industry.
Specific Knowledge:
GMP, GLP, ICH and FDA regulations and Tech Transfer procedures. Knowledge of formulation development (equipment and production processes), Regulatory affairs knowledge. Solid products knowledge.
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