Deviation Writer/Technical Writer (Pharmaceutical)

Job Summary
Seeking 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 Responsibilities

Write 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 Qualifications

Bachelor'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 Skills

Deviation Investigation Writing

GMP Manufacturing Experience

Root Cause Analysis (5 Why, Fishbone)

CAPA Development

Technical Writing

Pharmaceutical/Biotech Industry Experience

Quality Systems (eQMS, EDMS)

Cross-Functional Collaboration

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