5+

Experience in QMS activities (Change Controls, Investigations, Incidents, & CAPA preparation) Disinfectant preparation, Media Preparation, MLT, BET & Sterility Method Validations Executions & Documentation

Conduct comprehensive nitrosamine and elemental impurities risk assessments for new products, technology transfers, and commercial products life-cycle changes.

Handling of Reactors, Centrifuges, Driers & Good Documentation, and Good safety Practices.

Experience with regulatory requirements specific to vaccines / biological products. Responding to deficiency letters & authority queries.

Experience in cell based assays and functional testing techniques including ELISA, receptor-based assays, cytotoxicity assays, and bioanalytical methods

Responsible for coordination with all sales personnel across India for providing them appropriate Product and Sales Support.

Analytical method validation raw data and report review for different techniques like LC-MS/GC-MS/ICP -MS/ICP OES-MS for all regulated markets, Characterization & GMP Batch analysis.

Should have experience in the operation and calibration of GCMSMS / LCMSMS. Method development and validation; Preparation of reports.

Responsible for FG testing, stability studies and analytical validation. Handling in-process QA, line clearance and compliance monitoring