Tech Transfer Technician
hace 2 semanas
**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.
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 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 project-related 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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