Project & Run Support - Quality Expert - All Genders

il y a 1 semaine

Craponne, France bioMérieux Temps plein

**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.

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