Técnico Especialista - IPT Producción Biológica Inactivada
Core
Provide technical support for the Inactivated Biological Production IPT to execute production activities within quality and safety standards, manage production data analysis, and lead research and corrective actions.
Role type
Senior Technical Specialist (Biological Production)
Builds
Inactivated biological products for pharmaceutical use
Domain
Pharmaceutical manufacturing / Biologics
Required skills
GMP compliance, cGMP compliance, Data Analysis, Process Monitoring, Regulatory Compliance, Equipment Set Up, Lean Manufacturing Tools, Environmental Health and Safety (EHS) Management, SAP application, Reliance application, LABWARE system, MEDS system
Preferred skills
Advanced English, Audit experience, Change control management, Deviation management, CAPA management, Project improvement leadership
Technologies
SAP, Reliance, LABWARE, MEDS, e-logs, Trend
Responsibilities
Manage change controls and deviations/CAPA in Reliance; Lead improvement projects; Prepare research reports on area products; Manage production documentation (manufacturing instructions, technical work instructions, equipment operation instructions); Collaborate on product transfers to the plant; Participate in audits; Generate and analyze production data; Contribute to plant Key Performance Indicators.
Seniority
Senior, hands-on IC
