- Eseguire analisi chimiche e chimico-fisiche di materie prime, acque farmaceutiche (PW, WFI, PS) API e Prodotti Finiti, anche citotossici, in ambito GMP, all'interno del Laboratorio di Controllo Qualita' (nel seguito "Lab-QC").
- Utilizzare e contribuire alla gestione dei principali strumenti analitici di Laboratorio da applicare in analisi di tipochimico e chimico-fisico: HPLC, UPLC, GC, Titolatori, FT-IR, KF, ecc.
- Eseguire e sviluppare metodi analitici su piccole molecole organiche (non biologici) e inorganiche per analisichimiche e chimico-fisiche di principi attivi, materie prime, intermedi di processo e prodotti finiti, anche citotossici, e monitoraggio utilities.
- Convalidare o verificare in accordo con ICH, USP, EP, BP, JP, ecc. metodi analitici su piccole molecole organiche e inorganiche da trasferire al Lab-QC.
- Documentare le attivita' mediante la redazione di protocolli, report di convalida, verifica e Method Transfer.
- Interfacciarsi con i laboratori esterni per specifiche attivita' analitiche: es. collettare risultati di analisi relative astudi di stabilita' svolte da laboratori terzi e farsi parte attiva nella gestione di eventuali investigazioni dovute aOOS o Deviazioni.
- Almeno 5 anni di esperienza con prodotto finito
- Esperienza di lavoro in sterile, oltre ovviamente alla conoscenza del lavoro in GMP.
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senior chemical analyst - Monza e Brianza, Italia - Technical Hunters srl
Descrizione
SENIOR CHEMICAL ANALYST - MONZA E DELLA BRIANZALuogo di lavoro: Monza e della brianza
Nota realta' operante nel settore delle biotecnologie, ricerca una figura di Senior Chemical Analyst
Principali responsabilita'Il presente annuncio e' rivolto ad entrambi i , ai sensi delle leggi 903/77 e 125/91, e a persone di tutte le eta' e tutte le nazionalita', ai sensi dei decreti legislativi 215/03 e 216/03.
Titolo di studio minimo: Comune e/o quartiere: Monza e della brianza