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Quality Consultant - Compliance - FDA - Beerse, Belgium
Eingestellt von Elevate Direct
Gesuchte Skills: Consultant, Engineering, Engineer
Projektbeschreibung
Quality Consultant - Compliance - FDA - Beerse, Belgium
Within the Janssen Diagnostics (JDx) organization, the Digital and Diagnostics Quality Department is responsible for the quality overview of new product development on one hand and commercialized products on the other hand. The service provider will enable support within the JDx Quality
Department by Project management and priority management for the QA department:
*Supports key projects and initiatives to standardize and harmonize quality systems to align with the Pharmaceutical Quality System strategy.
*The implementation of ISO 13485: 2016/IVDR and MDR requirements into the QMS.
*Data Integrity project: implementation of the J&J Enterprise and regulatory requirements into the lab environment.
*New Product Development projects:
*Providing Quality Engineering support and quality oversight to assure there is appropriate execution and documentation of design controls, process validation, process development for new products, supplier development and failure investigations.
*Supporting the Janssen Diagnostics (JDx) Business with Quality Issues and Quality records (ie Non-conformances, CAPA's, Change controls and complaint records), ensuring appropriate investigation and (creation, review and approval of) documentation and making recommendations for Corrective and Preventive Actions.
*Provides support during inspections and audits for JDx.
*Collecting and reporting metrics for the different Quality processes and supporting the preparation of the JDx Quarterly Review Meetings and JDx Management Review.
*Collaborates with cross functional groups to drive process improvements and regulatory compliance.
*Works independently on projects of high complexity and determines solutions and recommendations.
*Coaching/training of Janssen Diagnostics associates where needed.
*Collaborates with key stakeholders to ensure business and quality needs are met.
*Helps QA to drive change management within Janssen Diagnostics.
Education and knowledge
University degree - medical or paramedical (pharmacy, biology, engineer in technical disciplines, or other scientific degree or equivalent by work experience).
Experience in Quality Systems.
Knowledge of relevant regulations (FDA 21CFR part 820, EMA, ISO 13485, CLIA/CAP)
Outstanding written and oral communication skills in English
Computer knowledge
Knowledge of molecular biological assays
Project management skills
People management skills
Communication skills
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.
Within the Janssen Diagnostics (JDx) organization, the Digital and Diagnostics Quality Department is responsible for the quality overview of new product development on one hand and commercialized products on the other hand. The service provider will enable support within the JDx Quality
Department by Project management and priority management for the QA department:
*Supports key projects and initiatives to standardize and harmonize quality systems to align with the Pharmaceutical Quality System strategy.
*The implementation of ISO 13485: 2016/IVDR and MDR requirements into the QMS.
*Data Integrity project: implementation of the J&J Enterprise and regulatory requirements into the lab environment.
*New Product Development projects:
*Providing Quality Engineering support and quality oversight to assure there is appropriate execution and documentation of design controls, process validation, process development for new products, supplier development and failure investigations.
*Supporting the Janssen Diagnostics (JDx) Business with Quality Issues and Quality records (ie Non-conformances, CAPA's, Change controls and complaint records), ensuring appropriate investigation and (creation, review and approval of) documentation and making recommendations for Corrective and Preventive Actions.
*Provides support during inspections and audits for JDx.
*Collecting and reporting metrics for the different Quality processes and supporting the preparation of the JDx Quarterly Review Meetings and JDx Management Review.
*Collaborates with cross functional groups to drive process improvements and regulatory compliance.
*Works independently on projects of high complexity and determines solutions and recommendations.
*Coaching/training of Janssen Diagnostics associates where needed.
*Collaborates with key stakeholders to ensure business and quality needs are met.
*Helps QA to drive change management within Janssen Diagnostics.
Education and knowledge
University degree - medical or paramedical (pharmacy, biology, engineer in technical disciplines, or other scientific degree or equivalent by work experience).
Experience in Quality Systems.
Knowledge of relevant regulations (FDA 21CFR part 820, EMA, ISO 13485, CLIA/CAP)
Outstanding written and oral communication skills in English
Computer knowledge
Knowledge of molecular biological assays
Project management skills
People management skills
Communication skills
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Ingenieurwesen/Technik, Organisation/Management