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Assistant Manager, QA Validation at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

30 Jun, 26

Salary

0.0

Posted On

01 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Validation, Cleaning Validation, Hold Time Study, Media Fill, Batch Sampling, URS Review, DQ Review, Vendor Qualification, Validation Protocol Preparation, Qualification Report Review, Risk Assessment, Manufacturing Coordination, Engineering Coordination, QC Coordination, Execution of Validation Activities, Re-Qualification

Industry

Pharmaceutical Manufacturing

Description

Responsible for Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP. Responsible for review of URS, DQ and vendor/ supplier’s documents related to qualification. Responsible for preparation and review of Validation/ Qualification protocol and report. Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities. Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities. Responsible for preparation and review of media fill and hold time protocol and report. Responsible for preparation, review and execution of risk assessment activity related to equipment/ process/ facility/ system

Responsibilities

The Assistant Manager, QA Validation is responsible for process validation, cleaning validation, and coordinating validation activities with various departments. They also prepare and review validation protocols and reports, ensuring compliance with established standards.