
SME | Sterility Assurance
7 days ago
Role & responsibilities
- To take care of Sterility Assurance
- Involved and well aware about Aseptic processing area requirement, personal qualification, Aseptic practices and concept
- Daily round at shopfloor for review and gap assessment.
- To do transfer Sterility assurance trending
- Aseptic area cleaning requirement and practices, on spot cleaning checking
- CCIT
Preferred candidate profile
- Exposure in PFS, Cartridge, Vial filling line process
Knowledge about sterility assurance concept - Knowledge of Contamination control strategy and risk assessment
- Aware of Environment Monitoring concept
- Acquainted with media fill concept, BMR, Regulatory requirement
- Acquainted and involved in smoke study concept, execution and review w.r.t sterility practices
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