Senior Associate, Manufacturing Technical Support
hace 6 días
**Summary**: The Remote Senior Associate, Manufacturing Technical Support, provides support for all process-specific issues to manufacturing. **About the Role**: **Responsibilities**: - Authors manufacturing investigations and meets all targets for timely closure and CAPA completion. - Supports steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy. - Performs first line evaluation of product and process related issues (deviations, complaints, OOS, OOE). - Provides and supports assessments of technical changes, establishment of root-cause analysis, Quality Risk Assessment and process control strategies. - Supports process optimization establishment and new technology introduction for continued productivity improvement, as appropriate. - Supports the execution of process validations, and short-term improvement projects, collaborating with all the relevant parties at shop floor to ensure accurate execution. Launch & Transfer - for the product(s) assigned. - Revises the master manufacturing documents of assigned products (e.g. Master Batch Record, Bill of Material (BOM) & Recipe, Quality Risk Assessment, Hazard Analysis). - Ensures creation of production SOPs and revisions to Master Batch Records and/or Electronic Records. - Maintain processes at inspection readiness level. - Ensures that all critical parameters are within written Instruction (e.g. Master Batch Record, Quality Risk Assessment, and Validation Protocol). - Supports data collection for ongoing process verification, support manufacturing lead in tracking and evaluation of product performance and implementation of CAPAs. - Reviews protocols and reports for technical correctness. - Other related duties as assigned. **Requirements**: - Bachelor’s degree in Engineering, Biology, Chemistry, Biotechnology, or applicable field and 2 years of work experience in biopharmaceutical based GMP manufacturing operations. - Master’s degree in Engineering, Biology, Chemistry, Biotechnology, or applicable field and 1 year of work experience in biopharmaceutical based GMP manufacturing operations. - Fluent in English. Excellent oral and written communication skills. Strong technical writing ability required. - Travel, as required, to other internal sites (
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Specialist, Manufacturing Technical Support
hace 1 semana
Insurgentes, México Novartis A tiempo completo**Summary**: Job Description Summary The Specialist, Manufacturing Technical Support, provides expert support for all process-specific issues to manufacturing, to ensure execution of processes on-time, continuously improving in quality and productivity, performed in compliance to GMPs, SOPs and applicable guidelines and functional standards. **About the...
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Specialist, Manufacturing Technical Support
hace 6 días
Insurgentes, México Novartis A tiempo completo**Summary**: The Specialist, Manufacturing Technical Support, provides expert support for all process-specific issues to manufacturing, to ensure execution of processes on-time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards. **About the Role**:...
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Senior Supply Chain and Logistics Specialist
hace 5 días
Insurgentes, México Novartis A tiempo completo**Summary**: The Senior Supply Chain and Logistics Specialist is responsible for coordinating and managing end-to-end order fulfillment for CGT (Cell and Gene Therapy) shipments, ensuring timely execution of manufacturing, quality release, and distribution. This role serves as the primary point of contact for scheduling production starts, final product...
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Technical Support L1
hace 6 días
Insurgentes San Borja, México TD SYNNEX A tiempo completoAt TD SYNNEX Mexico, we are a leading team in the distribution of IT solutions and services that collaborates globally. We are a _Great Place to Work _that seeks to improve the welfare of our employees, enhance their development through training and certification at a technical level to provide the best service to our Vendors and Channels.**Job Purpose**This...
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Associate Process Expert
hace 6 días
Insurgentes, México Novartis A tiempo completo**Summary**: This role will author and oversee deviations, investigations, CAPAs, and related reports to closure within established timelines for the manufacturing department. **About the Role**: **Deviation and Investigation Management**: - Open deviations within required timeframes - Author investigations - Owning investigations and developing corrective...
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Rlt Account Customer Support Associate
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Insurgentes, México Novartis A tiempo completo**Summary**:**About the Role**:**Major Accountabilities**- Complete customer support activities including but not limited to product administration scheduling, associated order management and delivery- Answer questions from Novartis NPS field associates to provide support to customers. Partner with cross-functional stakeholders to provide accurate and timely...
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Documentation Specialist
hace 2 semanas
Insurgentes, México Novartis A tiempo completo**Summary**: This Role provides oversight of all GMP documents ( SOPs, FRMS, WPS) and ensures that all documents are updated, trained and effective in alignment with the department needs **About the Role**: **Major accountabilities**: - Revise existing or create new SOPs in time to support Manufacturing Strategy. - Ensure periodic review is completed on...
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Associate Process Expert
hace 2 semanas
Insurgentes, México Novartis A tiempo completo**Summary**: This role will author and oversee deviations, investigations, CAPAs, and related reports to ensure closure within the established timelines for the manufacturing department. **About the Role**: **Deviation and Investigation Management**: - Open deviations and assess the criticality of the deviation within required timeframes - Assess impact to...
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Senior Supply Chain Logistics Specialist
hace 2 semanas
Insurgentes, México Novartis A tiempo completo**Summary**:The Senior Specialist Supply Chain Logistics, is responsible for coordinating the order processing for drug shipments. This role is the point of contact to schedule manufacturing, warehouse and Quality for logistic timelines of drug shipment.**About the Role**:**Major accountabilities**:- Provides cross functional coordination in the scheduling...
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Associate Director, Business Operations
hace 3 semanas
Insurgentes, México Novartis A tiempo completo**Summary**:**About the Role**:Key Responsibilities:- Direct and manage daily Business Operations activities, ensuring alignment with US-based department/functional team standards, priorities, and ways of working.- Coordination of all aspects, in consultation with US functional lead, of Mexico City-based associate lifecycle management including recruitment,...