- 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.
- 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 ISO
- 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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Project & Run Support - Quality Expert - All Genders - CRAPONNE, France - bioMérieux
Description
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
Who are you?
bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.