Sign up with

Already have an account? Log in here

Need some help?
Talk to us at +91 7670800001

Senior Executive, Validation Engineering, Technical Writing at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

04 Oct, 26

Salary

0.0

Posted On

06 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Validation Engineering, Technical Writing, Installation Qualification, Operational Qualification, Performance Qualification, SOP Management, Change Control, Calibration Scheduling, Preventive Maintenance, BMRAM, Caliber QAMS, Epiq DMS, Vaisala Viewlinc

Industry

Pharmaceutical Manufacturing

Description

 To prepare validation documents such as Installation qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and other Qualification documents for equipment /utilities/facilities and generate reports which summarize results, specification and its acceptance criteria.  To track for SOPs due for review, circulating for comments, updating of comments, initiate change control, initiate ERA workflow and follow-up for execution, approval and closure.  To prepare Monthly Calibration Schedule and Preventive Maintenance Schedule as per US FO requirements.  To upload/review calibration reports in BMRAM and other BMRAM related activities.  To work in Caliber QAMS, Epiq DMS and Vaisala Viewlinc system.  To arrange Quotes for new equipment as and when requires. Additional Responsibilities:

Responsibilities

Prepare validation documents including IQ, OQ, and PQ for equipment and facilities and generate corresponding summary reports. Manage SOP reviews, change controls, calibration schedules, and preventive maintenance activities.