Job Description

Hello,
I hope you're doing well.

My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Deviation Writer based in 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 vyshnavi.t@intellectt.com

Position: Deviation Writer
Location: Onsite - Indiana
Duration: 6 Months
Hours per week: 40 Hours per Week

Position Summary
We are seeking an experienced Deviation Writer to support Manufacturing Engineering by investigating and documenting deviations, non-conformances, and technical events in a GMP-regulated environment. The role involves collaborating with cross-functional teams to perform root cause investigations, develop corrective and preventive actions (CAPA), and ensure compliance with quality and regulatory requirements.

Key Responsibilities

• Investigate and document deviations, non-conformances, and technical events.
• Gather facts, analyze data, and work with Subject Matter Experts (SMEs) to determine root causes.
• Utilize root cause analysis tools such as 5 Whys and Fishbone (Ishikawa) diagrams.
• Develop effective corrective and preventive actions (CAPA).
• Translate complex technical information into clear, concise investigation reports.
• Collaborate with Manufacturing, Quality, Engineering, Supply Chain, and other stakeholders.
• Review historical deviations and identify trends to drive continuous improvement.
• Maintain documentation within electronic Quality Management Systems (eQMS) and EDMS platforms.

Required Qualifications

• Bachelor's degree in Science, Engineering, or a related technical field.
• Minimum 3 years of technical writing experience in a GMP-regulated environment (pharmaceutical, biopharmaceutical, or biotechnology preferred).
• Strong understanding of GMP manufacturing processes and regulatory requirements.
• Experience with root cause investigations and CAPA development.
• Proficiency in Microsoft Word, Excel, and electronic document management systems.

Preferred Skills

• Excellent technical writing and documentation skills.
• Strong analytical, organizational, and problem-solving abilities.
• High attention to detail and ability to work independently.
• Effective communication and collaboration with cross-functional teams.

Thanks & Regards

Vyshnavi
Recruiter
Intellectt Inc
vyshnavi.t@intellectt.com
Direct: 732 204 6550
Desk number: 732 412 6999 - Ext: 225

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