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Quality Consultant - Quality Engineer - QC - Validation

Eingestellt von Elevate Direct

Gesuchte Skills: Engineer, Consultant, Engineering

Projektbeschreibung

QUALITY CONSULTANT/BEERSE, BELGIUM/10 MONTHS CONTRACT/40 TO 45 EUR (PER HOUR)

JOB DESCRIPTION

* Supports key projects and initiatives for JDx to standardize and harmonize quality systems to align with the Pharmaceutical Quality System strategy.

* Provides support during inspections and audits for JDx.

*.Collaborates with cross functional groups to drive process improvements and regulatory compliance.

* Maintains up-to-date knowledge of all key relevant regulations (FDA, EMA, ISO, CLIA/CAP etc.).

* Project management and priority management for the QA department.

* Develops alternative solutions for QA challenges and improvement opportunities (eg partly outsourcing of equipment validation).

* 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.

* The service provider will enable support within the quality department of JDx, by 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 (re)design, execution, training and continuous improvement of applicable Quality processes and ensures company and departmental policies and procedures are in place to deliver to company goals and objectives and ensure regulatory compliance. 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. Ensuring that for Quality related issues the communication and escalation is performed according to the effective procedures. Collecting and reporting metrics for the different Quality processes and supporting the preparation of the JDx Quarterly Review Meetings and JDx Management Review.

NON TECHNICAL SKILLS AND ADDITIONAL DETAILS

University degree - medical or paramedical (pharmacy, biology, engineer in technical disciplines, or other scientific degree or equivalent by work experience).

Experience in Validation/Quality Systems.

Knowledge of relevant regulations (FDA, EMA, ISO, CLIA/CAP)

Outstanding written and oral communication skills in English

Computer knowledge Qualifications

Project management skills

People management skills

Communication skills

THE COMPANY

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

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

  • Einsatzort:

    Beerse, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    10 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Elevate Direct