Technical Writer (Automation/Validation)
: Job Details :

We are seeking a Technical Writer with expertise in Automation/Validation to manage and revise documentation within enterprise systems. This role requires ensuring data integrity and compliance with regulatory standards (21 CFR Part 11, GAMP 5, ISPE). Responsibilities include reviewing and pushing document workflows for approval, ensuring accuracy, expediting approvals, and managing change controls. Strong communication and interpersonal skills are essential for effective collaboration and follow-ups.

Requirements:

• Expertise in Data Integrity Compliance, 21 CFR Part 11, and GAMP 5.
• Experience with ISPE guidelines and Change Control processes.
• Familiarity with Automation and Validation principles.
• Strong attention to detail and the ability to manage multiple documentation workflows.
• Excellent communication and organizational skills.