The candidate will be expected to be key member of the the Quality Control department to participate mainly in the following activities:

- Management of the Biological laboratory

- Development, laboratory supervision, document review and validation of microbiological (Bioburden, endotoxins, analysis of water for injection, environmental monitoring) analytical methods (SDS-PAGE, Western Blot, Determination of total protein concentration, ELISA, qPCR, control of water plant for injectables, etc).

- Writing protocols and validation reports.

- Writing protocols and stability reports.

- Writing protocols and reports of analytical method transfers.

- Elaboration and revision of Standard Operating Procedure (SOPs).

- Management of corrective actions, deviations, change controls, release of materials, out-of-specification results, risk management, etc.)