23 ene
Novartis
Xico
.
**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**:**Responsibilities**:- Revises master manufacturing documents of assigned products (e.G.
Master Batch Record, Bill of Material (BOM), and Recipe, Quality Risk Assessment, Hazard Analysis).- Ensures that all critical parameters are within written Instruction (e.G.
Master Batch Record, Quality Risk Assessment, and Validation Protocol).- Supports steward for assessment of technical changes,
establishment of root-cause analysis, Quality Risk Assessment, process control strategy.- Ensures that all process changes in assigned products are managed through appropriate change control procedure.- Ensures creation of production SOPs and revisions to Master Batch Records and/or Electronic Records.- Act as Subject Matter Expert (SME) for the product and process knowledge, be highly knowledgeable of product and process trends by providing input for analysis and driving process technology innovations.- Authors manufacturing investigations and meets all targets for timely closure and CAPA completion.- Supports data collection for ongoing process verification, support manufacturing lead in tracking and evaluation of product performance and implementation of CAPAs.- 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.- Maintains processes at inspection readiness level.- Supports process optimization establishment and new technology introduction for continued productivity improvement.- Reviews validation protocols and reports for technical correctness.- Revisions to the master manufacturing documents of assigned products.- Other related duties as assigned.
**Requirements**:- B.S.
degree in Engineering or the life sciences and 5 years of work experience in biopharmaceutical based GMP manufacturing operations or 3 years relevant GTx experience.- Experience in the development of manufacturing documentation and in the investigation of complex manufacturing deviations.- In-depth knowledge of FDA regulations and GMP systems and experience providing process support in a highly regulated or pharmaceutical / biotech facility.- Applied knowledge of Quality by Design, six-sigma,
and operational excellence tools in creating efficient and high-quality processes and end products.- Fluent in English.
Excellent oral and written communication skills.
Strong technical writing ability required.- Travel, as required, to other internal sites (< 10%)
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