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T
T

Sterility Assurance Lead

Thermo Fisher Scientific Inc

Ferentino
4 giorni fa
Ferentino
4 giorni fa

Organisational Level

Position is equivalent to QA Operations Manager / QA Compliance Manager and reports to the site Quality Director

  • Depending on the size/complexity of the site the incumbent may or may not have man management responsibilities.
  • Incumbent will need to operate within a matrix management system to deliver their key responsibilities
  • Probably fulfils the role of site Microbiologist (SME) but is not the QC Microbiology Manager

Purpose of the Role

Single person accountable for sterility assurance across site and will own/promote/define the systems listed as key responsibilities.

Key Responsibilities:

  • Contamination control strategy (define/own/maintain for the site)
  • EM & APS program (define/oversee/improve)
  • Aseptic Comportment/Training/Oversight (Manage)
  • Sterilization processes (oversee)
  • Risk assessments and improvement programs (implement/manage - against current and future expectations)
  • Lead major investigations into issue impacting sterility Assurance (i.e. Adverse EM trends, media fill failures)
  • Review & approve any Major/Critical deviation and any change proposals with Sterile Assurance impact (lead)
  • Staying up to date with best practice and sharing that knowledge (10% of time should be devoted to this)
  • Act as SA SME for the above with regulators / clients (i.e. key part of major audits)
  • Act as SA SME for new product introduction and for applicable capital projects (i.e. new lines/processes)
  • Implementing best practice (e.g. ensuring understanding / compliance with SA related regulations & guidance – owning the transition and any risk assessments we need)
  • Represent site on the Sterile Working Group (potential future team leader) actively harmonizing practices across sites in the network
  • Report status of and promote Sterility Assurance within the Senior Leadership Team (lead)
  • Audit other sterile sites and suppliers providing microbiological service or sterile materials (as required)

Qualifications:

  • Relevant science based degree; e.g. Microbiology, Applied Biology.
  • Management qualifications (or equivalent experience).

Experience:

  • Typically from a microbiology QC background, ideally within a sterile manufacturing site.
  • Substantial experience working in a pharmaceutical quality function, preferably within a sterile manufacturing site.
  • Has intimate knowledge of sterile processing at a supervisory/management level, ideally will have managed one or more sterile production lines.
  • Experience with validation of sterile processes would be advantageous
  • Involvement in capital projects (new build/refurbishment of sterile lines) would be advantageous
  • Intimate knowledge of Annex 1 and similar guidance
  • Leadership experience
  • Own – SAL personal responsibility

    Manage – SAL owns content, someone reporting to SAL (dotted line) executes.

    Define – SAL sets expectations (in harmony with QS & SWG) & signs off on system.

    Oversee – SAL provides independent review of system to ensure its defined correctly & working correctly

    Improve – SAL spots issues and initiates corrections. System owner executes.

    Implement – SAL puts this in place either alone or with dotted line resource

    Demonstrable audit/client facing experience.

Key Skills:

  • Influencing
  • Curiosity
  • (What we are attempting to do is make the SAL define the EM system, oversee its effectiveness, identify any weaknesses and initiate any required improvements. To make this work they probably should be a dotted line arrangement in place between the SAL and other members of staff ).

S
S

ADDETTO/A RIFORNIMENTO DISTRIBUTORI AUTOMATICI

Synergie Italia S.p.a.

Frosinone
12 giorni fa
Frosinone
12 giorni fa

Synergie Italia, filiale di Frosinone, ricerca per cliente del settore servizi-distribuzione:

ADDETTO/A RIFORNIMENTO DISTRIBUTORI AUTOMATICI


La persona dovrà occuparsi del rifornimento di distributori automatici presenti sul territorio di Frosinone e Provincia, occupandosi del carico e scarico dei prodotti nonché di gestione contabile relativa alla cassa del distributore


Il/la candidato ideale ha conseguito il Diploma o titolo di studio equivalente, possiede la patente B e ha disponibilità immediata al lavoro.


Si offre: contratto di lavoro a tempo determinato in somministrazione con prospettive di assunzione successiva diretta da parte dell'azienda. Orario di lavoro: full-time lun/sab. Luogo di lavoro: territorio del Frusinate

I candidati ambosessi (L.903/77) sono invitati a leggere l'informativa privacy Regolamento (UE) 2016/679 Aut. Min. Prot. N. 1207 - SG del 16/12/2004

H
H

Production Manager - Settore Chimico

HUMAN VALUE S.R.L.

Italia/Lazio/Frosinone
30+ giorni fa
Italia/Lazio/Frosinone
30+ giorni fa

Il Contesto

Grazie all’innovazione continua, atta a soddisfare le esigenze del mercato, il nostro cliente è riconosciuto come un Brand di grande rilievo nel settore della distribuzione di prodotti chimici per l’industria B2B. Per merito di un supporto tecnico avanzato, affianca i propri clienti sin dalle prime fasi di R&D per permettere loro di ottimizzare l’intera Supply Chain e le fasi legate allo sviluppo e formulazione di nuovi prodotti.
Con l’obiettivo di potenziare ulteriormente la propria struttura, siamo stati incaricati di ricercare il:
Production Manager - Settore Chimico
Sede di lavoro: provincia di Frosinone
 

Il Ruolo

A riporto del Supply Chain & Operations Director, il candidato prescelto avrà la piena responsabilità di un sito operativo, assicurandone l’ottimale esecuzione delle attività di distribuzione, stoccaggio, confezionamento, miscelazione/dissoluzione e favorendone l’efficientamento. Garante della sicurezza dei dipendenti e degli impianti, coordinerà, attraverso i suoi primi riporti, tutte le risorse allocate all’interno della struttura logistico-operativa in un contesto caratterizzato da elevata complessità organizzativa, per numero di prodotti e volumi di merci movimentate. Lavorerà alla definizione del budget di sito e ne assicurerà la realizzazione, adottando le soluzioni più idonee al raggiungimento degli obiettivi.
Avrà una responsabilità trasversale su:
  • Salute, Sicurezza e Tutela dell’Ambiente – per garantire il rispetto di tutte le direttive in materia;
  • Qualità – al fine di assicurare l’applicazione di protocolli e sistemi qualità;
  • Logistica e Operazioni – per ottimizzare l’intera Supply Chain, dalla ricezione dei prodotti alla loro distribuzione;
  • Area Tecnica – per attuare piani di manutenzione degli impianti e realizzare investimenti mirati a garantire l’ammodernamento degli stessi;
  • Persone – garante della politica gestionale HR sul sito, favorire l’attuazione di piani di sviluppo delle proprie risorse, oltre a gestire il fabbisogno di risorse e governare il budget del costo del lavoro.

I Requisiti

  • Laurea Magistrale in Ingegneria, idealmente chimica, o equivalente
  • Esperienza di almeno 3-5 anni, in un ruolo di coordinamento di risorse, maturata all’interno di contesti industriali chimici o della distribuzione di prodotti chimici per l’industria caratterizzati da complessità organizzativa in termini di articoli e volumi stoccati/movimentati;
  • Propensione all’analisi dei processi volta al miglioramento degli stessi attraverso il monitoraggio e l’efficientamento di KPI/SLA in ambito di eccellenza nel servizio al cliente;
  • Sarà particolarmente apprezzata la provenienza da contesti multinazionali strutturati e che possano rappresentare un modello nella gestione dell’intera Supply Chain;
  • Ottima padronanza della lingua inglese;
  • Capacità gestionali e organizzative, team building, doti di leadership e autorevolezza completano il profilo.
Nessun altro risultato

Pubblicato

4 giorni fa

Descrizione

Organisational Level

Position is equivalent to QA Operations Manager / QA Compliance Manager and reports to the site Quality Director

  • Depending on the size/complexity of the site the incumbent may or may not have man management responsibilities.
  • Incumbent will need to operate within a matrix management system to deliver their key responsibilities
  • Probably fulfils the role of site Microbiologist (SME) but is not the QC Microbiology Manager

Purpose of the Role

Single person accountable for sterility assurance across site and will own/promote/define the systems listed as key responsibilities.

Key Responsibilities:

  • Contamination control strategy (define/own/maintain for the site)
  • EM & APS program (define/oversee/improve)
  • Aseptic Comportment/Training/Oversight (Manage)
  • Sterilization processes (oversee)
  • Risk assessments and improvement programs (implement/manage - against current and future expectations)
  • Lead major investigations into issue impacting sterility Assurance (i.e. Adverse EM trends, media fill failures)
  • Review & approve any Major/Critical deviation and any change proposals with Sterile Assurance impact (lead)
  • Staying up to date with best practice and sharing that knowledge (10% of time should be devoted to this)
  • Act as SA SME for the above with regulators / clients (i.e. key part of major audits)
  • Act as SA SME for new product introduction and for applicable capital projects (i.e. new lines/processes)
  • Implementing best practice (e.g. ensuring understanding / compliance with SA related regulations & guidance – owning the transition and any risk assessments we need)
  • Represent site on the Sterile Working Group (potential future team leader) actively harmonizing practices across sites in the network
  • Report status of and promote Sterility Assurance within the Senior Leadership Team (lead)
  • Audit other sterile sites and suppliers providing microbiological service or sterile materials (as required)

Qualifications:

  • Relevant science based degree; e.g. Microbiology, Applied Biology.
  • Management qualifications (or equivalent experience).

Experience:

  • Typically from a microbiology QC background, ideally within a sterile manufacturing site.
  • Substantial experience working in a pharmaceutical quality function, preferably within a sterile manufacturing site.
  • Has intimate knowledge of sterile processing at a supervisory/management level, ideally will have managed one or more sterile production lines.
  • Experience with validation of sterile processes would be advantageous
  • Involvement in capital projects (new build/refurbishment of sterile lines) would be advantageous
  • Intimate knowledge of Annex 1 and similar guidance
  • Leadership experience
  • Own – SAL personal responsibility

    Manage – SAL owns content, someone reporting to SAL (dotted line) executes.

    Define – SAL sets expectations (in harmony with QS & SWG) & signs off on system.

    Oversee – SAL provides independent review of system to ensure its defined correctly & working correctly

    Improve – SAL spots issues and initiates corrections. System owner executes.

    Implement – SAL puts this in place either alone or with dotted line resource

    Demonstrable audit/client facing experience.

Key Skills:

  • Influencing
  • Curiosity
  • (What we are attempting to do is make the SAL define the EM system, oversee its effectiveness, identify any weaknesses and initiate any required improvements. To make this work they probably should be a dotted line arrangement in place between the SAL and other members of staff ).

Fonte: Thermo Fisher Scientific Inc