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  • Location

    Rotterdam, Netherlands

  • Job title:

    Quality Assurance Manager

  • Sector:

    Medical Devices

  • Job type:

    Permanent

  • Job ref:

    44050

  • Startdate:

    2020-05-14

Quality Assurance Manager

The Company

For a Rotterdam based Pharmaceutical company a Quality Assurance Specialist is needed to assist the Quality Team at it's sites located in the South East of the Netherlands

Role Description

Reporting to the site QA Director you will responsible for the sites QMS. You delegate daily QA tasks consisting off deviations, CAPA's, change controls, batch release and complaints handling to your team (5FTE). Additionally you are focused on site improvement projects, supporting internal and external stakeholder and training of new staff.

Responsibilities

  • Training new staff and manage the team of 5 FTE
  • Preform Internal and external audits
  • Working within cross-functional team
  • Maintain QMS - GMP
  • Document control 
  • Liaise with external customers - complaint handling
  • Batch review/release

Requirements

  • BSc in related field
  • Minimum 7+ years of experience within a QA environment
  • Excellent working knowledge of GMP, ISO 9001 and ISO 13485
  • Knowledge of Regulatory Affairs
  • Previous experience to set up training programs
  • You speak / write fluent Dutch and English
  • Team player and self-starter

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