Quality Assurance Engineer - CQV/QMS Support in Merck Corsier-sur-Vevey

veröffentlicht
Kontakt
Monika Kowalska, Randstad Merck Aubonne
Jobtyp
Temporär
jetzt bewerben

job details

veröffentlicht
Ort
Merck Corsier-sur-Vevey, Waadt
Sektor
Administration
Jobtyp
Temporär
Referenznummer
129085-38980
Kontakt
Monika Kowalska, Randstad Merck Aubonne
Telefon
+41 21 900 35 28

Stellenbeschreibung

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

Qualifikation

  • 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