quality assurance engineer - cqv/qms support in Merck Corsier-sur-Vevey

posted
contact
Monika Kowalska, Randstad Merck Aubonne
job type
temporary
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job details

posted
location
merck corsier-sur-vevey, vaud
sector
administration
job type
temporary
reference number
129085-38980
contact
monika kowalska, randstad merck aubonne
phone
+41 21 900 35 28

job description

An exciting new opportunity has arisen to be a part of a project to build State-Of-The-Art Biotech Development Facility in Switzerland.You will contribute to the development of the digital strategy and the support of the need of a new biotech site. The Biotech Development Center (BDC) is our next flagship biotech investment in line with our ambition to become The Vibrant Science and Technology Company and of our Healthcare business sector's strategy to become a Global Specialty Innovator and always better serve our patients.

Job Description

  • Review and approve all CQV documents for process equipment, lab equipment, - SAT protocols/reports- IOQ protocols/reports- Review deviations associated with all phases of CQV
  • Host or participate in Risk Assessments
  • Participate in establishment of site QMS

qualification

  • Minimum bachelor's degree in scientific discipline
  • 7-8 years of experience in a pharmaceutical/biotechnology environment
  • At least 5 years of field experience in commissioning, qualification, and validation of equipment
  • Knowledge in GAMP and CSV regulations
  • Expert knowledge of equipment validation standards
  • Experience in working with other quality professionals to establish QMS system
  • Experience working in project environment
  • Have a proactive approach to all aspects of Quality
  • Good communicator, dealing directly and efficiently with project teams and Merck personnel
  • 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