Quality Records Owner

  • Brabant
  • 3500.00 - 4000.00
  • 32-40 hours
  • Bachelor degree

Client

Our client is a consultancy company in the food and pharmaceutical industry.

Client

Our client is a consultancy company in the food and pharmaceutical industry. They participate in challenging projects with experienced engineers in the pharmaceutical industry. They offer challenging, varied projects with ample opportunities for personal contributions and development.

Requirements

  • Bachelor degree.
  • Fluent in English, with advanced technical writing skills.
  • 1-year experience with Change Control, Non Conformances and CAPA-programs within a GMP regulated environment.
  • Knowledge of regulations Eudralex Annex 15, FDA CFR 11, 210 and 211.
  • Experience in interacting with regulatory agencies highly preferred.
  • Six Sigma Green or Black belt preferred.
  • Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), Root Cause Analysis (RCA).

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

  • Identify root causes, evaluate optimal solutions, and recommend comprehensive improvements in order to prevent recurrence of issues.
  • Ensure records are completed to the highest standards, fully compliant with all regulations and quality standards.
  • Be the owner of Change Control, NC and CAPA records via Trackwise.
  • Facilitate and lead Root Cause Analyses to resolve issues.
  • Review for completeness of actions and records, accuracy, effectivity, and timelines.
  • Ensure compliancy and effectiveness of the records.
  • Cooperate with other sites to ensure compliance to global requirements are achieved in order to improve the quality system.

TAGCLOUD

CAPA
#compliance
#recordsowner
#nonconformance
#trackwise
#QMS
#qualityassurance
#QA
#changecontrol
#GMP
#pharma
Peter Debrichy

Interested

Send your resume to peter@tailorminds.com referring to job id (1034)

More information?

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

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