About this role

  • Posted on

  • Location

    Liege

  • Salary

    £42000.00 - £50000.00 per annum

  • Type

    Permanent

  • Division

    Pharmaceutical Quality Assurance Jobs

  • Reference

    BBBH19672UK_1625042617

  • Start date

    ASAP

  • Managing this role

Consultant

Urszula Kaldi

+44 (0) 203 8543 089

urszula.kaldi@xplorepharma.com

154-158 Shoreditch High Street

Description

Responsibilities

By integrating the Production department, aiming at the production and purification of proteins or plasmids, the function will consist mainly in:

  • Drafting and approving the URS of the computerized systems of the production equipment
  • Drafting and / or approving qualification documents for computerized production equipment systems
  • Manage (in collaboration with fermentation / purification and maintenance & validation managers) the qualification of computerized production equipment systems (FAT / SAT / IQ / OQ / PQ)
  • Manage validation computerized systems of production equipment
  • Develop SOPs and implement maintenance programs for computerized systems
  • Ensure the maintenance of the operational / qualified / validated / maintained status of the computerized systems of production equipment, and support changes / updates through the change control procedure
  • Ensure compliance with the integrity of data generated by production equipment (Data Integrity) according to current requirements
  • Be the point of reference for the production department for the implementation of computerized systems (LIMS, Trackwise, Smartsheet, etc.)
  • Be the interlocutor of the IT department and auditors

Qualifications

  • Industrial engineer, Master in science, or equivalent
  • Knowledge of the networking of GMP equipment (software and hardware)
  • Basic knowledge of database management (eg Microsoft SQL)
  • Experience in the bio-pharmaceutical industry
  • Mastery of computer tools (Excel, Word, equipment operating systems, automation).
  • Proficiency in technical English

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