Upgrade Post project

Quality Engineer Validation Consultant - Pharmaceuticals - Netherlands

South Holland  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Audit Support Quality Engineer Communication Analysis Documentation Crystal Reports Application Test Design

Description

Quality Engineers Validation Consultant/Leiden, Netherlands/10 Months Contract/44 to 69 EUR (Per Hour)

The Role

Johnson & Johnson are seeking Quality Engineer Validation Consultant to optimize systems and processes that are aligned with Mentor's strategy and mission effecting continuous quality improvement.

The Company

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

Principal duties and responsibilities

  • Supports, consults, trains on, and leads quality improvement projects throughout the life cycle of Mentor products this includes product design and development, manufacturing, purchasing and improvements.
  • Utilize statistical tools and techniques to establish sampling plans. Supports engineering activities in process and vendor specification development.
  • Analyzes process-, product-, test- and Quality Management System data and investigates for improvement opportunities.
  • Responsible for pFMEA documentation and leading pFMEA meetings.
  • Reviews validations documentation (eg. IQ, OQ, PQ and verification studies).
  • Leads or is team member of CAPA investigation and action plans.
  • Leads or is team member of Internal audit observation investigation and action plans.
  • Investigate instances of nonconforming material and supports the determination of cause, corrective action and recommendation of the disposition of product.
  • Ensures that software validations are performed according to applicable FDA guidelines. Provides end user support by software validation throughout the Software Validation Life Cycle at The Netherlands Operations.

    • Experience and qualifications:

    • University/Bachelor level in engineering or science
    • Basic statistical analysis tools
    • Relevant experience
    • Experience with Pharmaceutical/Medical Device companies
    • Knowledge of software and process validations
    • Knowledge in Statistics
    • Sufficient knowledge about computer systems and programming with Crystal Reports
    • Pro Active
    • troubleshooting and Risk Assessment/Risk Management minded
    • Tact
    • High level of accuracy
    • Flexible and Service minded
    • Able to identify and simplify complex issues
    • Communication skills
    • Fluent in English, Dutch Please note: Strongly theoretical role (reviewing documentation, identify gaps and solving these, making the company 'audit-proof'.

    This role is to prepare for new audit system to use next year.

    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.

    Start date
    In a month
    Duration
    10 months
    From
    Elevate Direct
    Published at
    05.07.2017
    Project ID:
    1374429
    Contract type
    Freelance
    To apply to this project you must log in.
    Register