Location

• Ahmedabad

Department

• Software

Job Description

• Review the user/operation manual for all products
• Review audio/visual/text training manuals
• Establishing document management system
• Coordinating with various HOD (Sales, Service, Operations, Design& Development, Testing, IT, HR etc.)  to identify various documents required, prepare templates, plan and track to completion. (This includes QMS)
• Up gradation of portals
• Develop documentation for end users; including User Manuals, Online Help, Installation Guide, Technical Admin Guide, Release Notes
• Validation of system according to cGMP Guidelines
• Preparation of qualification documents such as IQ, OQ, PQ, DQ; Preparation of User Requirement Specification
• Standard Preparation of the Manual like Product, Operational, Installation, Maintenance, Trouble Shooting and Training
• Review Product Qualification Documents
• Product Development Planning and Tracking Documentation as per requirements

 Educational Qualification

• Tech / B. Pharm / M. Pharm

Experience

• 12 – 15 Years

Desired Candidate Profile

• 10 years’ experience in a relevant context
• A degree in a relevant subject or demonstrated ability to deliver the responsibilities required
• Experience in using documentation tools like MSOffice Suite, Adobe Frame maker, SnagIt, Adobe RoboHelp, Adobe Acrobat, MS Visio
• Very good understanding for Documentation Development Life Cycle (DDLC) or Technical Writing process and documents involved in SDLC
• Knowledge of different standards and compliance for documentation, Knowledge on GAMP5
• Knowledge on ISO and CMMI process is added advantage
• Experience in different work domain like Software Validation, Technical Trainer, and Technical Support
• Knowledge of various style guides like Microsoft Manual of Style (MSTP), and company specific style guides
• Experience in writing, rewriting and editing- technical and research documents, case studies, manuals and training content
• Excellent organizational and planning skills, with an ability to multitask in a busy environment with multiple contacts
• Effective communication skills, both verbally and in written form at all levels of authority
• Experience of working in international development/ operational management would be advantageous