Job Description
Required Experience :
> Minimum 2 to 6 Years of experience in Injectables / Parenteral pharma industry having USFDA / Other regulatory approvals.
> Knowledge of regulatory Guideline.
Job responsibilities:
> Preferably must have working experience of Environment Monitoring.
> Preparation of Validation SOPs.
> Preparation of Validation protocols like; URS, DQ, IQ, OQ and PQ.
> Working experience of Execution of Process validation activities like;
- Water System Qualification
- AHU Qualification - HEPA Filter Qualification & Smoke Studies.
- Clean room area qualification
- Sterilization Validation for Bacterial Challenge
- Depyrogenation Tunnel Validation
- Sterility Test Method Validation and Preferably Sterility Testing.
- Bacterial Endotoxin Test Method Validation & Preferably performed BET Testing.
- Bioburden Test Method Validation & Preferably performed Bioburden Testing.
- Interphase Lethality Validation
- Process Simulation Study
> Knowledge of Risk Assessment.
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