Senior Executive, Validation Engineering, Technical Writing

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Amneal Pharmaceuticals in Ahmedabad is seeking a validation professional to prepare IQ/OQ/PQ and related qualification documents for equipment and facilities. The role includes initiating change controls, tracking SOP reviews in E-DMS, and managing calibration schedules per US FO guidelines.

The candidate should have a B. Pharm with preferred M. Pharm and 5–8 years of experience in pharmaceutical validation and asset management. This is a full-time position based in Gujarat, India.

Qualifications

• Experience in preparing validation documents for equipment/utilities/facilities.
• Familiar with IQ/OQ/PQ across pharma systems.
• Aware of change control and document closure processes.

Responsibilities

• Prepare validation documents such as IQ, OQ, PQ and other qualification docs for equipment/utilities/facilities.
• Initiate change control and other documents in Caliber QAMS and close tasks.
• Track SOPs due for review, circulate for comments, update comments and initiate workflow in E-DMS.
• Prepare Monthly Calibration Schedule and Preventive Maintenance Schedule per US FO requirements.
• Review Calibration reports and asset management in BMRAM.
• Update required status and database for engineering workflow.

Skills

IQ/OQ/PQ docs

Change control

E-DMS workflow

Calibration management

Education

B. Pharm

M. Pharm

Job description

Job Description

• To prepare validation documents such as Installation qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and other qualification documents for equipment /utilities/facilities.
• To initiate change control and other documents in Caliber QAMS and closure of tasks.
• To track SOPs due for review, circulating for comments, updating of comments and initiating workflow in E-DMS.
• To prepare Monthly Calibration Schedule and Preventive Maintenance Schedule as per US FO requirements.
• Review of Calibration reports and asset management in BMRAM.
• Updating of required status and database for engineering workflow.

Education & Qualifications

• B. Pharm - Required
• M. Pharm - Preferred

Experience

• 5 years or more in 5 - 8 Years