JOB RESPONSIBILITIES :-
The candidate will perform QC testing of bacterial vaccines, including potency, identity, and physicochemical analyses. The role involves handling bacterial vaccines, performing in‑vitro assays (as applicable), and ensuring compliance with pharmacopeial and regulatory guidelines for vaccine release and stability testing.
- Knowledge on testing bacterial vaccines testing such as Typhoid conjugate vaccine, Diphtheria bulk testing, Tetanus bulk testing and Td vaccine testing is highly preferrable.
- Experience in handling HPLC, Dionex, UV-Spectrophotometer, Multimode plate reader and ELISA
- Shall be well versed with Biochemical assays (Protein, O-acetyl) immuno-chemical assays and electrophoresis,
- Knowledge in calibration and qualification of equipment and instruments.
- To perform/ monitor activities in compliance with GMP/GLP/GDP and record keeping.
- Experience in preparing SOPs, Specification, STPs and Study protocols
- To prepare method validation protocol and execute method validation.
- Experience in handling stability studies and maintaining records.
- Role shall require to coordinate with engineering/ maintenance department or third party labs as and when required.
- Should possess basic skills in MS-Office, LIMS & SAP
- Knowledge of regulatory guidelines from WHO, CDSCO, and pharmacopeias are added advantage.
