04 Nov
|
Sapigen Biologix
|
Bhubaneswar
04 Nov
Sapigen Biologix
Bhubaneswar
Role & responsibilities
- Ensuring cGMP, GLP, GDP and safety compliance in all working areas
- Preparing and reviewing validation protocols, SOPs, STPs, specifications and reports
Sterility and BET testing of RM, PM, bulk and finished products
- Leading OOS/OOT/deviation investigations; following QMS for change control and CAPA
- Reviewing facility qualification, media-fill protocols, and qualification of autoclaves, isolators and tunnels
- Reviewing EMP and water trends, analytical data, CoAs and batch release
- Training and qualifying microbiologists; preparing JDs and training schedules
Risk assessment and contamination control strategy
- Supporting internal/external audits and coordinating with vendors and cross-functional teams
📌 Assistant Manager (Bhubaneswar)
🏢 Sapigen Biologix
📍 Bhubaneswar