23 ene
Novartis
Xico
**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 (< 10%).DivisionOperationsBusiness UnitInnovative MedicinesLocationMexicoSiteINSURGENTESCompany / Legal EntityMX06 (FCRS = MX006) Novartis Farmacéutica S.A.
de C.V.Functional AreaTechnical OperationsJob TypeFull timeEmployment TypeRegularShift WorkNo**Accessibility and accommodation**:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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