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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

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Environment Monitoring, IPQA, Calibration Review, Aseptic Processing, Media Fill Simulation, Non-viable Particle Monitoring, Personnel Monitoring, Qualification Activities

Industry

Pharmaceutical Manufacturing

Description

1. Responsible to review environment monitoring, water trends. 2. Responsible for reviewing the different type of planner and calibration certificates. 3. Responsible to receive the required resources for EM monitoring e.g. plates, samplers, swabs etc. from microbiology laboratory and after completion of EM monitoring plates, samplers, swabs etc. should be handed over to microbiology lab for further process along with applicable formats which is filled in aseptic area. 4. To maintain the Issuance/reconciliation record of items / media for Environment monitoring material e.g. plates, swabs, etc. 5. Environmental monitoring of manufacturing clean room area as per the defined schedule. 6. Responsible for participating in media fill simulation study 7. Responsible for participating in performing qualification activities in the manufacturing area. 8. Non-viable particle monitoring of manufacturing clean room area as per the defined schedule. 9. Compressed air /nitrogen gas monitoring and Personnel monitoring. 10. Review of Media fill CD.

Responsibilities

Responsible for environmental monitoring of manufacturing clean rooms, including water trends and non-viable particle monitoring. The role involves managing EM resources, participating in media fill simulations, and performing qualification activities.