SENIOR EXECUTIVE QC

1. Receipt of in process, DS, reserve samples and stability samples and storage at QC location
2. Planning and performing In-Process, finished product and stability sample testing of monoclonal antibodies and biosimilars and reporting the results.
3. 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.
4. Preparation, qualification and life cycle management of cell banks used in bioassays
5. Preparation and review of method validation, method transfer, study protocol, Stability protocols and summary sheet (Compilation Data) and reports.
6. Planning and performing (Testing) of method transfer, method validation and study samples.
7. Verification of laboratory compliances, which include the validity checking of the reagents, standards, system status etc.
8. Reporting and investigation of Incidents, OOS, OOT and Deviation.
9. Calibration of analytical weighing balance, pH meter etc.
10. Qualification of Analytical instruments and Equipment (IQ/OQ/PQ) and Facility readiness
11. Adherence to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice) and GDP (Good Documentation Practice).
12. Ensure & Implementation of Data Integrity Culture in Quality Control Lab. 

•  1 - 4 years
• QC Experience in Biosimilars, Monoclonal antobodies testing

Science, Pharmacy graduates, post graduates