Specialist Technical Writing
The Judge Group Inc.

Job Info

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Location: Holly Springs, NC
Description: Our client is currently seeking a Specialist in Technical Writing

Minimum of 8-10 years of experience and strong working knowledge of GMP/regulatory requirements within the QC laboratory.

Must have experience writing the following technical documents within the QC laboratory: SOPs/ Equipment Operation and Maintenance Procedures/ Validation and Qualification protocols with little guidance.

• Create strong technically sound Standard Operating Procedures (SOPs), Operation and Maintenance (O&M) Procedures, Equipment Data Integrity Assessments, etc. required to support QC Laboratory Startup

• Process document changes within the electronic Quality Management System (eQMS) while ensuring good documentation practices (GDP)

• Manage document lifecycle updates to support QC Laboratory Readiness metric reporting

• Author Analytical Equipment Qualification Protocols (Performance Qualification Protocols) and Compendial Verifications

• Previous experience with the Pharmaceutical Industry, with a strong focus on GMP Quality Control

Contact: skumar09@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

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