Biotech and Pharmaceutical, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, GMP (Good Manufacturing Practices), Investigative Reports, Manufacturing, Manufacturing Operations, Microsoft Excel, Microsoft Word, Operational Support, Quality Engineering, Root Cause Analysis, Supply Chain, Technical Writing, Trend Analysis, Writing Skills
Hello,
I hope you're doing well.
My name is Jayadev, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Deviation Writer/Technical Writer (Pharmaceutical)
based in Fishers, Indiana with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at jayadev.g@intellectt.com
Position: Deviation Writer
Location: Fishers, IN
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
Thanks Regards,
JAYADEV
Sourcing Specialist
Phone (732)-997-6982 Ext: 308
Email jayadev.g@intellectt.com