Responsible for production activities
1. Monitoring of area drains cleaning and documents updation.
Updation of room / equipment status labels.
Verification of material required for production activities.
Preparation of area, equipments before batch activities.
Execution of production activities.
Monitoring of batch parameters.
Updation of batch parameters.
Samples handling (Sampling and labelling).
Intimation of incidents to Shift in-charge.
Assisting in column packing, unpacking and evaluation activity.
2. Chromatography column and resin monitoring.
3. Handling of documents
Checking practical feasibility of new / revised SOPs, protocols.
Updation of log books.
Updation of BMRs and attaching annexures online.
4. Responsible for operation of following production equipments (but not limited to):
AKTA Process Purification system Conductivity meter
AKTA Pilot Purification system Peristaltic pumps
TFF System Mixing Systems
LAFU Filter integrity tester
pH meter Heat exchanger
Walk in cold room Freezer room
5. Training:
Attending training on SOP's / GMP as per schedule.
6. Responsible for Quality Management Systems
Initiation of breakdown request.
Initiation of CRN's.
Initiation of incidents, Investigations and CAPA.Please enter job description