Job Objective: Lead the technical documentation team of R&D; facility and deliver documentation package of new product as per set standards. Primary
Responsibilities:
• Strategic and Planning:
• Planning for executing on-time delivery of Master Validation Documents, Master Operating Instructions, and Master Spare Parts Documents in-line with departmental goals.
• Foresee future needs and participate/contribute in continuous improvement of master documents of recent products.
• Participate/Contribute in continuous optimization of documentation process by adopting effective AI based solutions.
• Functional:
• Develop, implement and maintain master documents to align with strategy document
• Develop and implement Editorial Guide, Base Modules, documentation processes and Company standards
• Develop, implement and maintain review checklist for master documents
• Develop and control Standard Terminology
• Drive and control standard practices of PLM (Product Lifecycle Management), PDLC (Product Development Lifecycle) and DDLC (Document Development Lifecycle)
• Drive CFT (Design, A&C;, Manufacturing, and QA team) to review and gather input from various functions for improvement in the Instructions
• Drive and control ACG Standards for “Content Development” to develop uniform and consistent content
• Drive, facilitate and participate in master core team
• Review and Release machine-specific Master modules to prepare master documents
• Oversee project management for each master project
• Complete the project with the sign off on ‘handover form’ involving all stakeholders
• Ontime & First Time Right completion of Master Documents with a thorough review and release processes
• Understand various regulatory requirements, like, CFR part 21, GAMP V, Machinery Directive
• Understand the various internation writing standards like MSTP, STE
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• Internal Process:
• Support QA team to prepare templates of internal documentation.
• Support HOD to prepare and update departmental monthly report.
• Prepare and Maintain reports on CFT feedback and improvement actions suggested by various functions.
• People’s Development:
• Establish & Maintain Customer-Centric culture within documentation teams to fulfil desired customer need
• Create engaging work culture, establish effective feedback practices,
• Identify the team’s development plan and prepare a yearly calendar to facilitate training along with the HR team
• Measure/monitor individual development after completion of the training program. Education
• BE Mechanical/Production/Electronics
• Diploma in Technical Writing
• 8-10 years of experience
📌 Lead, Technical Documentation, Quality, SciTech Centre (Mumbai)
🏢 ACG
📍 Mumbai