Technical Documentation Specialist

SciTech Centre, a state-of-the-art, government recognized, centralized research facility is an ACG initiative, located in the heart of Mumbai. From dosage development to pharmaceutical engineering, the SciTech Centre aids the pharmaceutical industry by partnering in developmental activities. SciTech also has several successful patents registered under its name. SciTech employs several scientists, technologists, technicians, skilled research equipment operators for prototype development and researchers. Specific areas of SciTech's research activity include pharmaceutical engineering, advanced pharma dosage forms research, general research and dissemination of scientific information through conferences, study groups and travel grants. Its pharma engineering and dosage forms research has resulted in many projects incorporating novel prototypes and mechanisms, as well as dosage platforms.

We have an opportunity in SciTech Centre of a Lead technical documentation.

Job Objective: Lead the technical documentation team of R&D facility and deliver documentation package of new product as per set standards.

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

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.

Qualifications

• BE - Mechanical/Production/Electronics
• 8-10 Years overall experience in technical documentation

Technical Experience

• Experience with MS Office, FrameMaker, Adobe Acrobat, RoboHelp
• Experience with Content Management System (CMS) such as Microsoft SharePoint
• Knowledge of Photoshop, Adobe Illustrator, Snagit
• International technical writing standards such as simplified technical English (STE), MSTP (Microsoft Style of Technical Publications), IEC/IEEE 82079-1
• Experience in writing Pharmaceutical Validation/Qualification documents
• Understanding Engineering Product and Processes
• Knowledge of XML tools, DMS, CCMS, and related standard documentation practices
• Knowledge of regulatory requirements such as CFR part 21, GAMP V, Machinery Directive
• Knowledge on DDLC & SDLC