Scientist – QC

1. To coordinate all activities pertaining to HPLC section and to ensure their timely execution as per approved protocols and SOP, that includes analysis (batch release, stability, method development etc.) of recombinant monoclonal antibodies for peptide mapping, SEC, RP-HPLC, CEX, Glycan profiling etc. 2. Analytical method validation for all methods as mentioned above.
3. Technology transfer from client.
4. To coordinate with QA, Engineering, Manufacturing department and other section in QC for sampling, analysis, reporting of results and related activities in timely manner.
5. To prepare and review SOPs, STPs, DRS, specifications and protocols related to HPLC section.
6. Responsible for maintaining all documents in Quality control department such as SOP, Log Books, Specimen copy, DRS, STP, and Specifications etc.
7. To ensure proper usage of equipment, cleaning, preventive maintenance, calibration, verification and to ensure concurrent recording of data in respective log books.
8. To perform method optimization, qualification, validation and any other studies related to HPLC section.
9. To maintain inventory of all consumables in section.
10.To participate in Change Control and investigation to be carry out during deviation, OOS, market complaint and related CAPA.
11. Selection, supervision and performance appraisal of personnel reporting.
12.Management of Empower (Waters) projects i.e. monthly project creation, backup, deletion and restoring of empower projects.