Deviation Writer/Technical Writer (Pharmaceutical)

Job SummarySeeking an experienced Deviation Writer to support GMP manufacturing operations by investigating deviations, non-conformances, and quality events. The role involves root cause analysis, CAPA development, technical writing, and collaboration with cross-functional teams.Key ResponsibilitiesWrite and investigate GMP deviations, non-conformances, and quality events.Gather facts, review data, and determine root causes.Perform Root Cause Analysis using 5 Why and Fishbone methodologies.Develop and document CAPAs (Corrective and Preventive Actions).Review historical deviations and identify trends.Prepare clear and detailed investigation reports.Collaborate with Manufacturing, Quality, Engineering, MS&T, and Supply Chain teams.Required QualificationsBachelor's degree in Science, Engineering, or related field.4+ years of technical writing experience in a GMP-regulated environment.Strong knowledge of GMP, deviation investigations, CAPA, and quality systems.Experience with eQMS/EDMS systems.Proficiency in Microsoft Word and Excel.Must-Have SkillsDeviation Investigation WritingGMP Manufacturing ExperienceRoot Cause Analysis (5 Why, Fishbone)CAPA DevelopmentTechnical WritingPharmaceutical/Biotech Industry ExperienceQuality Systems (eQMS, EDMS)Cross-Functional Collaboration#J-18808-Ljbffr