Documentation Engineer

Role & responsibilities

BE/BTech in Mechanical/Electrical/Instrumentation/Industrial Production Engineering with around 1 to 2 years of experience and knowledge of process, process equipment and utilities of pharmaceutical manufacturing industry.

Candidate must have basic knowledge of GMP (Good Manufacturing Practices) requirements in the manufacturing environment of formulation facilities (both solid orals & sterile injectables). Candidate must know about requirement of documentation and preparation of GMP documents and should be willing learn and carry out independently with assistance.

Job Description:

• Preparation of URS for process equipment and clean utilities
• Preparation of SOPs
• Qualification documentation
• Validation protocols
• Risk assessment & mitigation plan
• Preparation of GMP layouts using AutoCAD
• Preparation of people & material flow
• Preparation of waste flow and knowledge of waste handling
• Preparation of concept note for designing of HVAC system and layouts for classification, Zoning and Differential pressure (DP).
• Preparation of URS for manufacturing facility
• Root cause investigation and preparing reports.