Quality Management System -BIOVIA

Job description

Company descriptionDescriptif de l'entreprise

Dassault Systèmes, the 3DEXPERIENCE Company, provides business and people with virtual universes to imagine sustainable innovations. Its world-leading solutions transform the way products are designed, produced, and supported. Dassault Systèmes’ collaborative solutions foster social innovation, expanding possibilities for the virtual world to improve the real world. The group brings value to over 200, 000 customers of all sizes, in all industries, in more than 140 countries. For more information, visit www.3ds.com.

3DEXPERIENCE, the Compass logo and the 3DS logo, CATIA, SOLIDWORKS, ENOVIA, DELMIA, SIMULIA, GEOVIA, EXALEAD, 3D VIA, BIOVIA, NETVIBES and 3DEXCITE are registered trademarks of Dassault Systèmes or its subsidiaries in the US and/or other countries.

BIOVIA, a wholly owned subsidiary of Dassault Systèmes is considered the leading provider of scientific innovation lifecycle management software, supports industries and organizations that rely on scientific innovation to differentiate themselves.

Job descriptionDescriptif du poste

Candidate's profileProfil recherché

Position SummaryRésumé du poste

Help define and manage the BIOVIA Software Quality Management System. Conduct customer Quality Audit program.

Position DescriptionDescriptif du poste

·  Demonstrates and proves DS commitment to established DS quality policy and objectives
·  Knowledgeable of quality management practices and standards including ISO 9001
·  Knowledgeable of the DS quality management deliverables including the sequence and interaction of core processes
·  Maps industry regulatory requirements to DS processes and operations in order to quickly prove compliancy
·  Builds and maintains industry or brand-specific quality management deliverables (FDA, Nuclear Regulatory Agency, Automotive SPICE, etc…)
·  Promotes quality awareness and communication within an Industry group or Brand
·  Supports customer quality management inquiries and audits
·  Keeps Industry and Brand leadership informed of quality management issues
·  Takes preventative action to mitigate risks to customer projects
·  Promotes continual improvement of DS processes and business practices

Type of contractType de contrat

EducationFormation académique

05-Bachelor's Degree

RequirementsExigences

Background :

There are several possible backgrounds for people who could successfully fulfill this role:

- QMS specialists from our competitors in the software industry

- Software validation specialists from our customers

- Professional software/IT auditors from the pharmaceutical industry

Competencies :

Some combination of the following competencies are needed, no one candidate will have them all and no one competency is critical

·  Conducting internal and external audits
·  Auditing credentials would be a big plus
·  Authoring SOPs
·  Experience working with software in validated environments
·  Experience validating software for use in Pharma
·  Knowledge of 21CFR part 11 (USA), Annex 11 (Europe) and/or equivalent Japanese laws

Keeping up with industry trends (subscribing to publications)

Motivation/Interests :

development of a QMS to serve an enterprise SOFTWARE company who uses agile development to develop products that are used in regulated space.

QualificationsQualifications

Compensation & BenefitsRémunération & Avantages Sociaux

How to apply?Comment postuler ?

Closing StatementsAvis