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Onesource Specialty Pharma Limited
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AM/DM/Manager-Microbiology (Sterile)

AM/DM/Manager-Microbiology (Sterile)

Onesource Specialty Pharma Limited

8 - 13 years

|

10 - 20 Lacs

Hyderabad Chennai Bengaluru

Posted:1 day ago| Platform:

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Skills Required

Process Support Environmental Monitoring Microbiology Analytical

Work Mode

Work from Office

Job Type

Full Time

Job Description

Lead and oversee Environmental Monitoring (EM) of controlled areas
Review and approve microbiological testing reports (sterility, BET, bioburden, MLT).
Manage aseptic process validations, media fills, and gowning qualifications.
Ensure compliance with regulatory guidelines (USFDA, MHRA, EU, WHO).
Handle deviations, OOS/OOT, CAPA, and change controls related to microbiology.
Conduct internal audits and face regulatory inspections.
Train and guide microbiology team members; manage workload and shift planning.
Approve SOPs, protocols, and EM trend reports.

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Onesource Specialty Pharma Limited

Onesource Specialty Pharma Limited

Pharmaceuticals

N/A

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