Company: SciTech Centre
- R&D; Centre of ACG Group

Location:
Jogeshwari, Mumbai

Education:
BE in Mechanical/Production/Electronics engineering/Diploma in Technical Writing

Experience:
8-10 years Industry: Pharma Manufacturing/Heavy Machinery Job Objective
-
• Preparation and review of Master Validation Documents (FS, HSD, SDS, HDTR, SDTR, I/O, ITR, FAT, IQ and OQ) to fulfil Master Documentation development plans Primary responsibilities
- Strategic and Planning:
• Planning for executing on-time delivery of Master Validation Documents in-line with departmental goals
• Participate/Contribute in continuous improvement of Master Validation Documents Functional
• Understand the PLM (Product Lifecycle Management), PDLC (Product Development Lifecycle) and DDLC (Document Development lifecycle)
• Understand the technical writing standards of the company and adhere to that during daily basis documentation tasks.
• Understand Editorial Guide/SOP’s, Base as well as Global modules and Company standards for Validation Documents and adhere to released documentation processes
• Understand the product and processes to be documented in Master Validation Documents
• Understand user requirements, design specifications, engineering drawings, BOM, ECN, URS, scope of supply, various features and options to create operating instructions and qualification documents.




• Planning for on-time delivery of documents in-line with departmental goals
• Collaborate with cross functional teams to obtain information and to review Master Validation Documents
• Develop and review operating instructions
• Develop and review the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualifications (OQ) and Factory Acceptance Test (FAT)
• Support QA during the FAT process for documentation sign-off
• Prepare and maintain reports of CFT feedback and improvement actions suggested by various functions
• Assist to keep track of change requests and follow correct change management process
• Drive and maintain customer centric culture within documentation team to fulfill desired customer needs
• Develop machine specific Master modules to prepare chapters of the Master Validation Documents
• Self-review of the Master modules, Master Validation Documents to ensure accuracy of documents
• Drive CFT review to receive inputs from various functions for improvement of Validation Documents
• Ontime & ‘First Time Right” completion of Master Validation Documents with reference to Editorial Guide/SOP’s, Technical Terms and Company standards.
• Collaborate with Engineering, Controls, Process, Service & QA team to Validate Documents
• Complete the project with “Project Acceptance Form” involving all stakeholders

📌 Documentation Engineer (Mumbai)
🏢 ACG World
📍 Mumbai