Quality Control- Sr. Executive

1. Preparation and Maintenance of SOPs, STPS, Specifications, GTP's and Worksheets related to Product testing.

2. Preparation, revision, review and execution of Analytical method Validation protocols and reports related to product testing.

3. Operation and calibration of QC Instruments related to product testing.

4. Testing and release of product samples by techniques such as:

General tests (Physical appearance, pH, Color, Extractable volume, Osmolality, Conductivity, etc.)

Gel Electrophoresis (IEF, SDS-PAGE, etc.)

Colorimetric assays (Sialic acid, Quantification of Polysorbate 80 and Polysorbate-20, etc.)

Quantification assays (Protein concentration by absorbance (Spectral scan)/Protein content by UV (OD @ 280 nm, Trehalose dihydrate, Mannitol, Sucrose, etc.)

ELISA's (Host Cell derived Proteins, Protein A Leachate, etc.)

Q-PCR (Host Cell DNA, Mycoplasma testing etc.)

HPLC techniques (Product concentration by RP-HPLC, Size Exclusion chromatography, Peptide mapping, etc.)

UPLC techniques (Cation exchange chromatography, Protein A Chromatography.

N-Linked Glycans by hydrophilic liquid interaction chromatography, etc.)

Capillary electrophoresis.

5. Preparation of reagent solutions, buffers and maintenance of the records.

6. Sample receiving, A.R.No allotment, Testing, Documentation and reporting of analytical results and Review in LIMS for In-process, batch release, stability and Miscellaneous samples related to product testing.

7. Withdrawal and aliquoting of batch release and stability samples for analysis.

8. Temperature and humidity monitoring of labs and instruments.

9. Responsible for CGLP compliance.

10. Responsible for handling of OOT (Out Of Trend), OOS (Out Of Specification), Incidents, LIRs and Change controls related to product testing.

11. Maintenance of stability samples and reserve samples related to product testing.