EM - QA

Role & responsibilities

• Environmental Monitoring in clean room area.
• Preparation of qualification documents, SOPs, Initiation of CC & Risk Assessment and preparation of Scientific rationale of EM locations.
• Line Clearance in Clean room area.
• Sampling of In-process sample and Bulk sample.
• Gowning Qualification in clean room area.
• Nitrogen gas and compressed air sampling.
• Initial and periodic qualification of HVAC and Equipments. (Viable, NVPC, DP monitoring, Recovery and smoke study)

Preferred candidate profile

Injectable and Opthalmic background