Sr. Manager Documentation (12-15 Years ) Ahmedabad

HypTechie; Ahmedabad District; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

HypTechie in Ahmedabad seeks a senior Documentation Specialist to lead documentation initiatives across product lifecycles. You will review manuals, establish a robust document management system, and coordinate with multiple departments to ensure quality content.

The role requires deep DDLC understanding, experience with end-user documentation, and familiarity with standards like GAMP5; validation docs IQ/OQ/PQ are also part of responsibilities.

Qualifications

• Extensive DDLC knowledge and technical writing experience.
• Experience with documentation SDLC processes and quality standards.
• Familiar with GAMP5, ISO and CMMI considerations are advantageous.
• Proficient use of MS Office, FrameMaker, RoboHelp and related tools.

Responsibilities

• Review user/operation manuals, training materials, and product docs.
• Establish and maintain a document management system across departments.
• Coordinate with Sales, Service, Operations, Design & Development, Testing, IT, HR, etc.
• Develop end-user documentation: User Manuals, Help, Installation & Admin guides, Release Notes.
• Prepare IQ/OQ/PQ and User Requirements Specifications for validation.
• Standardize manuals: Product, Operational, Installation, Maintenance, Troubleshooting, Training.
• Review Product Qualification Documents and track development documentation.

Skills

DDLC

Documentation writing

Organizational skills

Communication skills

Education

Tech

B. Pharm

M. Pharm

Tools

MS Office Suite

Adobe FrameMaker

SnagIt

Adobe RoboHelp

Adobe Acrobat

MS Visio

Job description

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