Quality Release Officer

  • Noord-Brabant
  • 3000.00 - 3500.00
  • 32-40 hours
  • Bachelor degree

Client

Our client is a leading project management and engineering company for industry around the world.

Client

Our client is a leading project management and engineering company for industry around the world. Their reputation is based on forming successful partnerships with their customers, offering them innovative designs and cost-effective solutions in the context of sound judgment, strong management and technical excellence. They offer Full Service Engineering for their customers, including project and program management, purchasing, design, construction management, health and safety management, commissioning, qualification and start-up for numerous projects in various market sectors.

Requirements

  • Bachelor degree (HLO) preferable in Biotechnology, Chemistry, or relevant field.
  • At least 2 years of relevant experience in the pharmaceutical industry.
  • Experience with quality and compliance guidelines and manufacturing processes.
  • Knowledge of Change Control, Root Cause Analyses, CAPA and deviations.
  • Technical knowledge in manufacturing/packaging processes and testing techniques.
  • Technical Writing, Root Cause Analysis, CAPA and Lean Six Sigma.
  • Team work oriented.
  • Excellent interpersonal and communication skills, oral and written (Dutch and English).
  • Experience with documentation system and SAP preferable.

What do you get?

  • Pension entitlement as from day one
  • Collective WGA / WIA insurance
  • NBBU / ABU collective labor agreement
  • 25 holidays days
  • 8,33% holiday allowance
  • 100% payment in case of illness after one waiting day
  • Travel allowance

Duties

  • Support the QP in more complex releases.
  • Have contact with the production floor about the route cause, changes and deviations and solve these issues in a solution-oriented way.
  • Execute batch records review including correlating actions in other systems.
  • Review and approve logbooks, log sheet, scleaning and sterilization records.
  • Prepare documentation package for release for products manufactured at site.
  • Support and approve investigations and CAPA plans.
  • Manage, evaluate and approve changes assuring they are in compliance with applicable SOP’s.
  • Participate in Quality Area projects to develop and implement improved/lean processes.
  • Prepare performance metrics for quality systems (BRs review, release data, complaints, investigations and their CAPA systems) on a monthly basis.

TAGCLOUD

qualityrelease
#GMP
#qualityassurance
#CAPA
#rootcause
#deviations
Peter Debrichy

Interested

Send your resume to peter@tailorminds.com referring to job id (950)

More information?

Please contact Peter Debrichy working at our office in Zoetermeer, phone number +31 6-10191580

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