Senior Executive, Validation Engineering, Technical Writing
Summary
Writes and maintains validation documents (IQ/OQ/PQ) for pharma equipment, tracks SOPs, and manages calibration schedules in compliance with US FDA requirements.
Job Responsibility:
❖ 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 for SOPs due for review, circulating for comments, updating of comments and
initiate 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.
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 5 years or more in 5 - 8 Years