Project & Run Support - Quality Expert - All Genders

il y a 1 mois

CRAPONNE, France bioMerieux SA Career Site - MULTI-LINGUAL Temps plein

bioMérieux 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 ?

 

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 

 

  1. 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.

 

  1. 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.

 

 

 

Working at bioMérieux means being involved long term with a pioneering, visionary and constantly growing company that allows its employees to live a stimulating and inspiring experience in a fulfilling work environment

Our internal mobility policy offers numerous opportunities for each of our 13 000 employees to blossom throughout their career, while respecting each employee’s individual talents as well as their personal and professional development.

At bioMérieux, over 200 professions - both scientific and non-scientific - offer our employees the opportunity to broaden their fields of expertise and develop cross-functional careers. We provide a rewarding experience in an international company that brings together talents from diverse backgrounds, thus fostering a daily aspiration to go beyond the limits.

Helping improve public health around in the world : our mission gives purpose to every profession practiced within the company.

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.

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