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