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Officer, IPQA at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

25 Aug, 26

Salary

0.0

Posted On

27 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Media Fill Simulation, Qualification Activities, Non-viable Particle Monitoring, Line Clearance, BMR Review, BPR Review, Process Validation, Cleaning Validation, Hold Time Study, In-process Testing, Environment Monitoring, Water Trend Analysis

Industry

Pharmaceutical Manufacturing

Description

1. Responsible to participate in media fill simulation study 2. Responsible to participate in perform qualification activities of manufacturing area. 3. Non-viable particle monitoring of manufacturing clean room area as per the defined schedule. 4. Compressed air /nitrogen gas monitoring and Personnel monitoring. 5. Responsible for line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labelling and packing. 6. Responsible for review of executed BMR’s and BPR’s. 7. Responsible for Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP. 8. Responsible to perform the in-process test at different stages as per batch document/SOP. 9. Responsible to review the environment monitoring, water trends.

Responsibilities

Responsible for conducting in-process quality assurance activities, including line clearance and monitoring of clean room environments. Oversees process and cleaning validations, media fill simulations, and the review of batch manufacturing and packing records.