EM - QA

Role & responsibilities

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

Preferred candidate profile

Injectable and Opthalmic background