Project & Run Support - Quality Expert - All Genders
il y a 3 semaines
**Project & Run Support - Quality Expert - All Genders**:
Location: CRAPONNE, France
Position Type: Unfixed Term
Job Function: Quality
A family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For 60 years and across the world, we have imagined and developed **innovative diagnostics solutions** to **improve public health**. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
We are looking for a Project & Run Support Representative (PRS) who will work and grow within the Computerized System Quality Support department and will report to Head of Project and Run Support team within a team of 6 co-workers.
**What will be your responsibilities within bioMérieux ?**
Within the Project & Run Support team, your role as Quality representative is essentially to ensure compliance with the execution of the Non Product Software (NPS) development process, in a strong regulatory context.
**Main Accountabilities**
- Project and RUN Activities for the Information Systems (IS) Department:
- Participate in IS projects with regulatory implications.
- Work closely with various members of the IS project teams to provide the necessary quality and regulatory support for project execution.
- Conduct functional and regulatory risk analyses.
- Develop and implement validation strategies for Non Product Software (NPS),
- Contribute to the Change Control process by challenging and validating impact analyses.
- Participate in periodic reviews to ensure the validated status of implemented solutions.
- Actively contribute to the improvement of IS processes to adapt to user needs and regulatory requirements.
- Monitor quality indicators.
- Cross-functional Activities**:
- Deliver training on Non Product Software Validation.
- Provide expertise and necessary advice to local entities for NPS validation and maintenance of validated status.
- Act as a key participant in the continuous improvement of NPS validation processes and methods at corporate level.
**Who are you?**
- Holder of a Master's degree (BAC + 5) with a minimum of 5 years of experience in computerized System Validation.
- You have a confirmed operational experience in quality processes supported by computerized systems, particularly in the healthcare industry.
- Experience in implementing digital and XaaS solutions is an advantage.
- You are an expert in the implementation of GAMP (Good Automated Manufacturing Practice).
- You have good knowledge of regulations and standards applicable to software development (such as 21 CFR Part 820, 21 CFR Part 11, ISO9001, and ISO13485).
- Conducting audits on regulatory aspects and standards would be a plus.
- You are pragmatic, autonomous, rigorous, and demonstrate the ability to synthesize information and have good interpersonal skills, with a strong capacity for listening and advising.
- Fluency in English, both spoken and written, is mandatory; proficiency in French is an asset.
-
Project & Run Support - Quality Expert - All Genders
il y a 1 mois
Craponne-sur-Arzon, Auvergne-Rhône-Alpes, France bioMérieux Temps pleinA family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network.Come...
-
Project & Run Support - Quality Expert - All Genders
il y a 1 mois
CRAPONNE, France bioMérieux Temps pleinA family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network.Come...
-
Project & Run Support - Quality Expert - All Genders
il y a 1 mois
Craponne-sur-Arzon, Auvergne-Rhône-Alpes, France bioMerieux SA Career Site - MULTI-LINGUAL Temps pleinbioMérieux S.A. Project & Run Support - Quality Expert - All Genders We are looking for a Project & Run Support Representative (PRS) who will work and grow within the Computerized System Quality Support department and will report to Head of Project and Run Support team within a team of 6 co-workers. What will be your responsibilities within bioMérieux ?...
-
IS Project Manager
il y a 1 jour
CRAPONNE, France bioMérieux Temps pleinActeur mondial dans le domaine du diagnostic in vitro depuis 60 ans, bioMérieux offre des solutions de diagnostic qui déterminent l’origine d’une maladie ou d’une contamination pour améliorer la santé des patients et assurer la sécurité des consommateurs. Nos équipes expertes dans les technologies de l'information, la data et la transformation...
-
IS Project Manager
il y a 1 jour
CRAPONNE, France bioMerieux SA Career Site - MULTI-LINGUAL Temps pleinOur IS EMEA&LATAM Regions department, within bioMérieux's IT Department, is looking for an Information Systems Project Manager to join a team of 13 employees on a permanent contract, reporting to the Head of the IS Project Managers team. What will your role be? As part of bioMérieux's IS project manager team, you will be responsible for:Ensuring...
-
Cybersecurity Operations Expert
il y a 3 semaines
CRAPONNE, France bioMérieux Temps pleinA family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network.Come...
-
IS Financial Controller
il y a 1 mois
CRAPONNE, France bioMérieux Temps pleinA family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network.Come...
-
IS Financial Controller
il y a 1 mois
CRAPONNE, France bioMerieux SA Career Site - MULTI-LINGUAL Temps pleinA family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution...
-
Cybersecurity Operations Expert
il y a 1 mois
CRAPONNE, France bioMerieux SA Career Site - MULTI-LINGUAL Temps pleinA family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution...
-
Data Science Manager
il y a 4 semaines
CRAPONNE, France bioMerieux SA Career Site - MULTI-LINGUAL Temps pleinA world leader in the field of in vitro diagnostics for 60 years, bioMérieux provides diagnostic solutions intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety.Our Industrial Microbiology Unit brings together more than 900 employees around...
-
Technical Support Specialist
il y a 1 mois
CRAPONNE, France bioMérieux Temps pleinA family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution...
-
Technical Support Specialist
il y a 1 mois
CRAPONNE, France bioMerieux SA Career Site - MULTI-LINGUAL Temps pleinA family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution...
-
Account Manager
il y a 1 mois
CRAPONNE, France bioMerieux SA Career Site - MULTI-LINGUAL Temps pleinbioMérieux S.A. Account Manager - All genders Les opérations commerciales France recherchent un Account Manager F/H/NB qui évoluera au sein du département Ventes Cliniques sur le secteur Sud Ouest de la France.Vous serez rattaché au Responsable Régional des Ventes.Poste idéalement basé sur le secteur (Bordeaux) Quelle sera votre mission...
-
Account Manager
il y a 1 mois
CRAPONNE, France bioMérieux Temps pleinbioMérieux S.A. Account Manager - All genders Les opérations commerciales France recherchent un Account Manager F/H/NB qui évoluera au sein du département Ventes Cliniques sur le secteur Sud Ouest de la France. Vous serez rattaché au Responsable Régional des Ventes. Poste idéalement basé sur le secteur...
-
compliance administrator
il y a 1 mois
CRAPONNE, France bioMérieux Temps pleinA family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network.Come...
-
compliance administrator
il y a 1 mois
CRAPONNE, France bioMerieux SA Career Site - MULTI-LINGUAL Temps pleinA family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution...
-
IS Area Relationship Manager
il y a 1 mois
CRAPONNE, France bioMérieux Temps pleinbioMérieux S.A. IS Area Relationship Manager - All Genders Notre département IS recherche un Area Relationship Manager qui évoluera en CDI au sein du département IS et sera rattaché au Domain Manager ARM au sein d’une équipe de 9 collaborateurs. Quelle est votre mission chez bioMerieux ? L'équipe Area...
-
IS Area Relationship Manager
il y a 1 mois
CRAPONNE, France bioMerieux SA Career Site - MULTI-LINGUAL Temps pleinbioMérieux S.A.IS Area Relationship Manager - All Genders Notre département IS recherche un Area Relationship Manager qui évoluera en CDI au sein du département IS et sera rattaché au Domain Manager ARM au sein d’une équipe de 9 collaborateurs. Quelle est votre mission chez bioMerieux ? L'équipe Area Relationship Manager EMEA LATAM gère...
-
IS Project Manager
il y a 1 jour
Craponne-sur-Arzon, Auvergne-Rhône-Alpes, France bioMérieux Temps pleinActeur mondial dans le domaine du diagnostic in vitro depuis 60 ans, bioMérieux offre des solutions de diagnostic qui déterminent l'origine d'une maladie ou d'une contamination pour améliorer la santé des patients et assurer la sécurité des consommateurs.Nos équipes expertes dans les technologies de l'information, la data et la transformation digitale...
-
IS Project Manager
il y a 1 jour
Craponne-sur-Arzon, Auvergne-Rhône-Alpes, France bioMerieux SA Career Site - MULTI-LINGUAL Temps pleinOur IS EMEA&LATAM Regions department, within bioMérieux's IT Department, is looking for an Information Systems Project Manager to join a team of 13 employees on a permanent contract, reporting to the Head of the IS Project Managers team. What will your role be? As part of bioMérieux's IS project manager team, you will be responsible for:Ensuring alignment...