Specialist Consultants
in the Pharma Sector

NonStop Pharma e' al momento alla ricerca di un/a figura di Regulatory Affairs Specialist con esperienza di e-CTD a nome di un'azienda farmaceutica globale con uffici in Europa, UK, Nord America ed Asia.

L'azienda e' nota soprattutto per la qualità dei prodotti che ricerca, sviluppa, produce e commercializza in tutto il mondo, avendo anche vinto alcuni premi in tale ambito.

La figura ricercata si occuperà di (in inglese inquanto si tratta di ruolo corporate):

• Support the Regulatory Department in the new registration procedure and e-submission
• General support to the e-Submission and documentation management process
• Participate in projects related to the work of Regulatory Ops
• Managing the submission of eCTD dossiers through the relevant portal
• Provide input to quality system (QAMS) documents
• Publish documents for electronic submissions in eCTD format

Il profilo ricercato ha:

Il nostro cliente offre contratto a tempo indeterminato, bonus legati ai risultati personali ed aziendali, benefit ai massimi livelli dell'industria e la possibilità di crearsi un percorso brillante in ambito affari regolatori all'interno di un'azienda nota in tutta Europa per la qualità del proprio operato.

Per applicare, il CV dovrà essere inviato in INGLESE, in formato word e completo di autorizzazione al trattamento dei dati personali (ai sensi del decreto legislativo n°196 del 30 giugno 2003 e del GDPR Regolamento UE 2016/679) a Nicolandrea Menichini - [email protected]

A causa dell'elevato numero di CV che ricevo quotidianamente, chiedo scusa in anticipo se non sarò in grado di garantire una risposta a ciascuno di voi.

Tenete in ogni caso presente che, essendo specializzato nel recruitment di professionisti in ambito Regolatorio e Farmacovigilanza, sono la persona giusta da contattare per queste posizioni sul mercato.

NonStop e' uno tra i principali provider di personale nel mondo Healthcare, con una crescita annuale superiore al 30%. Siamo orgogliosi membri di APSCo, un'organizzazione devota all'assicurazione della qualità dei servizi nel mondo del recruitment a livello globale. Per avere un'idea più chiara della portata dei nostri servizi non esitate a visitare il nostro sito http://www.nonstop-pharma.com od anche il mio profilo Linkedin.

Dans le respect des BPF et du système qualité, de la réglementation en vigueur, des règles d'hygiène-sécurité-environnement, des coûts et délais prévus :

Coordonner et être support pour les activités du service amélioration continue ;

Promouvoir l'application des réglementations en vigueur, des bonnes pratiques de fabrication/ distribution et des référentiels ISO dans les différents services ;

Planifier réaliser et suivre la qualification des équipements de production et des utilités ;

Planifier réaliser et suivre la métrologie de l'outil de production

Coordonner, les projets qualités assignés par le responsable (maitrise des changements, suivi audit internes/externes, amélioration, investigations, ou autres actions qualité).

Proposer à son responsable des améliorations pour le site et au sein du service.

PRINCIPALES RESPONSABILITE ET MISSIONS :

Dans le respect des procédures et des protocoles, « chargé d'amélioration Continue » doit :

1.Métrologie

• Réaliser le planning annuel de métrologie pour les équipements du site hors laboratoires et hors boucle d'eau :
• Réalisation des opérations de métrologie interne ;
• Encadrer les opérations de métrologie sous-traitées, suivre les non-conformités et les actions correctives.
• Réaliser les opérations en métrologie de conformité avec les réglementations en vigueur ;

2 qualification- validation

• Réaliser le planning de qualification annuel pour les équipements de production et les utilités ;
• Définir les stratégies de qualification ;
• Réaliser les opérations de qualification en conformité avec les réglementations en vigueur
• Rédiger les protocoles de qualification
• Réaliser les opérations de qualification interne
• Encadrer les opérations de qualification sous-traitées
• Suivre les non-conformités ou les anomalies suite aux qualifications ;
• Participer à la validation des opérations de nettoyage de l'outil de production.

3 Amélioration-continue

• Apporter un support aux activités suivantes :
• Assurer la réalisation et le suivi des audits internes ;
• Coordonner les maitrises de changement et s'assurer suivi des actions ;
• Coordonner les CAPA/ FAC et s'assurer du suivi des actions ;
• Coordonner et s'assurer de la mise en place des actions au sein des projets qualité
• Réaliser des formations qualités ( accueil BPF/ BPD, recyclage BPF , formation aux outils qualités, etc.)
• Réaliser le suivi des actions suite aux audits clients et inspections
• Aider à la rédaction documentaire du personnel de production (procédures , modes opératoires, etc)
• Apporter un support pour la rédaction documentaire des documents qualité su site
• Assurer la gestion documentaire du service et du site en collaboration avec les autres chefs de service , puis suivre leur mis en œuvre ;
• Préparer et anticiper aux inspections et audits du site de Décines ;
• Assurer la mise à jour des outils qualité informatique ;
• Assurer le suivi d'indicateurs ;
• Gérer les projets de validation
• Rédiger des analyses de risques en collaboration avec les autres services.

Formation

• Master 2 : qualification / métrologie /système qualité
• Expérience 3 à 4 ans d'expérience en Métrologie / qualification
• Polyvalent , rigoureux, volontaire , force de proposition, dynamique

Hai alcuni anni di esperienza nella calibrazione, taratura e validazione di strumenti nel mondo pharma?

Ti piacerebbe metterti in gioco all'interno di una realtà internazionale, stabile ed in forte crescita?

Sei alla ricerca di una posizione che possa garantirti un progetto tanto nel breve quanto nel lungo termine?

Continua a leggere ed applica subito a quest'offerta!

NonStop Consulting per un'importante realtà farmaceutica internazionale sta ricercando una figura di Calibration Specialist da inserire con contratto indeterminato in uno dei più attivi plant nel Veneto. Vi troverete a lavorare in una delle realtà più affermate dell'attuale panorama farmaceutico, andando a dare al vostro curriculum una nota di appeal ancor maggiore.

Il candidato ideale dovrebbe avere:

• almeno 3 anni di esperienza in validazione, calibrazione e taratura di strumentazioni nel mondo pharma.
• Propensione a lavorare in team, dovendo entrare all'interno del gruppo validazioni.
• Buona conoscenza della lingua inglese.

Il contratto, indeterminato, sarà inquadrato nel CCNL chimico farmaceutico con retribuzione da determinare sulla seniority del candidato.

Pensi quest'offerta faccia al caso tuo? Applica subito e ti ricontatteremo appena possibile!

Il CV dovrà essere inviato in formato word e completo di autorizzazione al trattamento dei dati personali (ai sensi del decreto legislativo n°196 del 30 giugno 2003 e del GDPR Regolamento UE 2016/679) a Matteo Massetti - [email protected]com

Se pensate che questo ruolo non sia adatto a voi potete andare sul nostro sito http://www.nonstop-pharma.it per avere un'idea più chiara sulla portata dei nostri servizi.

NonStop e' uno tra i principali provider di personale nel mondo Healthcare, con una crescita annuale superiore al 30%. Siamo orgogliosi membri di APSCo, un'organizzazione devota all'assicurazione della qualità dei servizi nel mondo del recruitment a livello globale. Per avere un'idea più chiara della portata dei nostri servizi non esitate a visitare il nostro sito http://www.nonstop-pharma.com od anche il mio profilo Linkedin: https://www.linkedin.com/in/pharmaitaly/

Calibration Specialist Pharma- Leading Engineering Company

Have you been working as a Calibration Specialist in the Pharma industry for a while and you feel that with the beginning of the New Year the time has come to accept a new challenge? Have you been looking to find that friendly environment in a company where you can build trustworthy relationships?

My client is a leading Engineering Company in Pharma Switzerland, with over 20 years of experience and proven record of providing quality services and solutions for their clients. They are looking to find professionals dedicated to long-term collaborations and who love growing up together with the company. What would that mean for you? Not only will you work in a pleasant and supportive environment where you would be appreciated for your skills, but you will also have that stability that you are looking for knowing that our client will invest in you.

Your profile

• A minimum of 5 years background in Instrumentation and Calibration in Pharma or Biotech industry
• Good knowledge and experience with GMP regulations
• Fluent in English, German might be a plus

If this sounds like the environment you have been looking for and it is the right time for you to make a change, let's have a chat! Call Malina Ion at NonStop Recruitment now for a confidential conversation. Contact me on [email protected] or +44 0207 940 2105, please send your CV in word format OR if this does not sound like the opportunity for you, but you are a freelance professional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, USA, Romania, Luxembourg and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

QA Specialist Supplier Qualification - Relocation Switzerland

A new opportunity for a QA professional is here! If you have been working in QA/QC for a while and are now looking to get more experience in Supplier Qualification, then you will have to read about this opportunity. My client is a multinational Pharma company who is known for their expanding new products and track of highly appreciated professionals that have built their experience in their company. They are now looking for a QA professional that is willing to be the contact point between them and the external suppliers and make sure that the manufacturing process is in line with the GMP guidelines. This can be your chance to gain more experience in quality manufacturing and bring a valuable set of skills to your resume.

Who are we looking for

• Previous experience in QA/QC with good knowledge of GMP practices
• Experience with regulations in Pharma (preferably in Medical Devices too)
• Good level of English and German

Does this sound like the opportunity to boost your career? Then let's have a chat! Call Malina Ion at NonStop Recruitment now for a confidential conversation. Contact me on [email protected] or +44 0207 940 2105, please send your CV in word format OR if this does not sound like the opportunity for you, but you are a freelance professional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, USA, Romania, Luxembourg and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

A regulatory service provider and consultancy are recruiting a CMC Technical Writer to start ASAP.

Located in Munich, the company are offering the option of home office if desired.

This is an English speaking position, however it is within a German company and therefore a willingness to learn German is desired.

The company supports all stages of drug development for EU and FDA submissions to over 500 clients globally in the areas of small and large molecules as well as biologics.

The Consultant "Technical writing CMC" supports the quality expert in the team for a broad range of drug substances and drug products by writing core quality sections for MAAs, BLAs/NDAs, IMPDs and INDs and briefing material to support agency meetings in the US and EU.

The company offers competitive salaries and flat hierarchies within a matrix organisation.

This is an opportunity to grow your network, expand your experience and challenge yourself.

Requirements:

A masters or PhD in the area of life sciences.

At least 2 years experience technical CMC writing and preferable experience with regulatory filings (IND/IMPD, BLA/NDA/MAA).

Get in touch today to find out more information. If this is not quite your area of interest, let me know and I can provide you with details about other vacancies on the market.

Unfortunately, non EU members will not be considered.