Role Summary
1) Ensure & Implementation of Data Integrity Culture in Quality Control Lab.
2) Adherence to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice) and GDP (Good Documentation Practice).
3) Qualification of Analytical instruments and Equipment (IQ/OQ/PQ) and Facility readiness.
4) Receipt of in process, DS, reserve samples and stability samples and storage at QC location.
5) Planning and performing In-Process, finished product (DS) and stability sample testing of Monoclonal antibodies and reporting the results. Enter batch result in SAP.
6) Preparation of stability protocol, registration and inventory in Nova LIMS.
7) Review of analytical reports of In process, finished product, stability, method validation, method transfer and study, Review of usage log books and Observation data sheets.
8) Preparation and review of method validation, method transfer, study protocol, Stability protocols and summary sheet (Compilation Data) and reports.
9) Planning and performing (Testing) of method transfer, method validation and study samples.
10) Verification of laboratory compliances, which include the validity checking of the reagents, standards, system status etc.
11) Reporting and investigation of Incidents, OOS, OOT and Deviation.
12) Supporting Operational Excellence, 5S in Quality control Lab.
13) Calibration of analytical weighing balance, HPLC, UV, IR, and pH meter etc.
14) Monitoring of EMS and reviewing the reports.
15) Review of ICDAS .
16) Maintenance of stability chamber, daily alarm log acknowledgement, temperature data verification.
Key Responsibilities
1) Ensure & Implementation of Data Integrity Culture in Quality Control Lab.
2) Adherence to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice) and GDP (Good Documentation Practice).
3) Qualification of Analytical instruments and Equipment (IQ/OQ/PQ) and Facility readiness.
4) Receipt of in process, DS, reserve samples and stability samples and storage at QC location.
5) Planning and performing In-Process, finished product (DS) and stability sample testing of Monoclonal antibodies and reporting the results. Enter batch result in SAP.
6) Preparation of stability protocol, registration and inventory in Nova LIMS.
7) Review of analytical reports of In process, finished product, stability, method validation, method transfer and study, Review of usage log books and Observation data sheets.
8) Preparation and review of method validation, method transfer, study protocol, Stability protocols and summary sheet (Compilation Data) and reports.
9) Planning and performing (Testing) of method transfer, method validation and study samples.
10) Verification of laboratory compliances, which include the validity checking of the reagents, standards, system status etc.
11) Reporting and investigation of Incidents, OOS, OOT and Deviation.
12) Supporting Operational Excellence, 5S in Quality control Lab.
13) Calibration of analytical weighing balance, HPLC, UV, IR, and pH meter etc.
14) Monitoring of EMS and reviewing the reports.
15) Review of ICDAS .
16) Maintenance of stability chamber, daily alarm log acknowledgement, temperature data verification.
Educational Qualifications
Required Education Qualification: Msc
Required Experience: 0 – 4 years
