qa engineer automation & csv validation in corsier-sur-vevey

posted
job type
temp to perm
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job details

posted
location
corsier-sur-vevey, vaud
job category
Administration
job type
temp to perm
reference number
129085-38544
phone
021 900 35 28
apply now

job description

Within the scope of a challenging, ambitious and future-oriented project driven by a dynamic team in an inspiring environment, Randstad is looking for A Quality Assurance Automation and CSV Engineer for Merck in Corsier-sur-Vevey for a 3 years contract for an engineer in CSV, Automation and Data Integrity.

Role

  • Define the automation and computerized systems quality strategy including data integrity aspects
  • Review and approval of GxP documents, including URS, traceability matrix, risk assessments, automation and Computerized systems drawings, procedures, qualification and validation documents…
  • Collaborate with the automation and Computerized systems project teams to ensure that all the deliverable meet quality specifications
  • Comply with all applicable health authorities regulations
  • Comply with all applicable company standards
  • Comply with the site software like LIMS, MES… if necessary
  • Perform the suppliers audit if necessary
  • Participate to risk assessments
  • Participate to health authorities inspection

qualification

Who you are

  • Minimum bachelor's degree in automation and/or computerized systems
  • At least 5 years of experience in a pharmaceutical/biotechnology environment
  • Knowledge in biotechnology process
  • Knowledge in cGMP and health authority expectations
  • Knowledge in GAMP and CSV regulations
  • Shows a desire and motivation to work in Quality and project environment
  • A proactive approach to all aspects of Quality
  • Good communicator, dealing directly and efficiently with project teams and global MBQ
  • Strong analytical and problem solving abilities
  • Organized and logical in defining workload and delivering projects
  • Fluent in English (written and spoken)
  • French is an advantage