EM - QA

Sentiss Pharma Pvt. Ltd.; Solan; In loco; INR 600.000 - 900.000; Tempo pieno

Descrizione del lavoro

Sentiss Pharma Pvt. Ltd. in Solan, India invites professionals with an injectable and ophthalmic background to join the Environmental Monitoring team.

The role emphasizes maintaining clean room integrity, preparing qualification documents, SOPs, initiation of CC & Risk Assessments, and ensuring proper line clearance in GMP facilities. Responsibilities include in-process and bulk sampling, gowning qualification, nitrogen gas sampling, and initial & periodic qualification of HVAC and equipment

Competenze

• Experience in environmental monitoring in clean room areas.
• Experience preparing qualification documents, SOPs, and risk assessments.
• Line clearance experience in clean room areas.
• Sampling of in-process and bulk samples.
• Gowning qualification in clean room environment.
• Nitrogen gas and compressed air sampling.
• Initial and periodic qualification of HVAC and equipment (viable, NVPC, DP monitoring, recovery and smoke study).

Mansioni

• 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)

Descrizione del lavoro

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