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QA Officer Compliance Process Reviewer

  • Location:

    Geel, Belgium

  • Contact:

    Sebastien Barxhon

  • Job type:

    Contract

  • Contact phone:

    0032 15445882

  • Industry:

    Pharmaceutical , Biotechnology

  • Contact email:

    sebastien_barxhon@oxfordcorp.com

Are you looking for a QA-position in a big biotech company?

Job Description

The QA Officer Compliance Process Reviewer works together with the MES project team (with the aim of successfully and timely implementing the project).The project team consists of employees from Manufacturing, QA Validation, IT, Automation. Successful from a QA perspective, this means conforming procedures and regulations without an impact to validated products and processes. This person will work together with other compliance officers where necessary under the supervision of a supervisor or manager.

Responsibilities
  • Guarantee compliance to procedures and regulations
  • First line contact for QA Compliance within the project team
  • Checking for “translation” of converted paper or electronic batch records (version update) to MES
  • Review and (where applicable) signing of related documents
  • Responsible for evaluating potential impact to process validation
  • Review of plans, protocols and reports
  • Drawing up a Quality Plan if applicable
  • Quality strategies in the meantime in consultation with QA supervisor (s) and QA Manager
  • Discuss and determine
  • Does the follow-up of any issues (quality events, deviations and investigations) and change related documentation so that they are closed on time
  • Where applicable, elaborate and follow up Gating Review (s)
  • Assist the other departments in solving compliance problems
  • Where applicable, completes all tasks as described in the relevant SOPs
  • Compliance with the SHE plan (safety, health and environment), by the right at all times
  • To use work equipment and personal protective equipment, to report (almost)
  • Incidents and non-conformities and assisting in the reporting of risks and preventive measures
  • Measures

Requirements
  • Junior/Medior profile in life sciences (bachelor/master biotech, biochemistry, pharmaceuticals,...)
  • Experience MES is a plus
  • Knowledge of electronic batches
  • QA experience
  • Teamplayer
  • Good knowledge of Dutch and English


Benefits
  • A challenging position until end of 2020, can probably be extended
  • Full-time - 40hrs / week – 5 days / week
  • Start date: August / September 2020
  • Competitive salary package