Lead, Technical Documentation, Quality, SciTech Centre

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 new 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