Content Writer - Validation Documents

www.acg-world.com

JOB DESCRIPTION-

Job Position: Content Writer - Validation Documents Department: Master Documentation

Grade: M8/M9 Reports to: Lead Master Validation Documents

Group Company: ACG Engineering Location: PAM Shirwal

Key Requirements:

Educational Qualification & Experience:

• Educational Qualification: Diploma/BE - Mechanical/Production/Electronics
• Desired additional qualification: Diploma in Technical Writing
• Experience: 4-6 Years

Target Companies

• Industry: Machinery, Engineering, Engineering Services
• Targeted Companies: Competitors and customers.

Job Objectives :

• 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

Core:

• Understand Editorial Guide/SOPs, 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
• Collaborate with cross functional teams to obtain information and to review Master

Validation Documents

• 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/SOPs, 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

Internal Process:

• Support Team lead to prepare and update departmental monthly report
• Prepare and Maintain reports on CFT feedback and improvement actions suggested by

various functions

People Development:

• Drive and maintain Customer Centric culture within documentation teams to fulfill desired

customers need

• Support team members to fulfil their job responsibilities
• Support Project documentation writer to implement Master Validation Documents for

projects

KRA

• Develop Master modules for Master Validation Documents using standard Technical

Terminology

• 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 in the Validation

Documents

• Validation of Master Validation Documents with first 3 customer projects
• Ontime & First Time Right completion of Master Validation Documents with reference to

Editorial Guide, Technical Terms and Company standards

Key Interfaces:

Internal Interfaces External Interfaces

• NPD/AE & Control teams (to receive the Engineering inputs & to

review master documentation)

• After Market teams (to receive site feedback and to align

documentation with After-Market requirements)

• Controls and QA team (for validation of master documentation)
• Supplier

Key Competencies:

Technical/Functional Competencies

(It will flow into Interview Assessment Form)

Leadership Competencies

(L-Compass as per grade)

• Fluent in both Spoken and written English
• Experience in writing Pharmaceutical Validation/Qualification

documents including Design Qualification (DQ), Installation

Qualification (IQ) and Operational Qualification (OQ)

• Exposure to GAMP 5 validation systems
• Experience with Computer System validation (CSV) and PLC validation

documentation

• Experience with Authoring tools, CMS, Adobe Acrobat, MS Office etc.
• Experience with handling pharmaceutical customer, FATs
• Communication
• Innovation
• Problem Solving
• Cross Functional Team

Working

• Quality and Service

Orientation

• Delivering Consistent

Results

warm Regards
vinaya Bagkar
HR Intern

ACG ENGINEERING

Telephone +91 7796872495

vinaya.bagkar@acg-world.com

www.acg-world.com

127, Kandivali Industrial Estate,

Kandivali (W), Mumbai - 400067