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Experienced CSV Senior/ lead

Ref: JN-072021-183693

Gepostet am 09 July 2021
Job Location
Valais
Kategorie
Life Sciences

Modis is searching an Experienced CSV expert, capable of leading a team on behalf of a client for a TEMPORARY position.

Your Tasks:

  • Create the requested CSV documents according the Guidelines
  • Organize the reviews of the CSV documents till last QA approval
  • Participate to the FAT & SAT
  • Create the tests protocols and execute the tests
  • Close collaboration with CQV Lead
  • Provide leadership of CSV activities in assigned Project(s) at Visp (together with PM, Process Engineers, EMR and QA):
  • Correct CSV project staffing, expertise and coaching to the CSV staff assigned to projects
  • Initiate necessary training on CSV-Staff / Project staff on CQV and CSV (supported by local CQV -Staff)
  • Address immediate time/quality constraints and act adequately
  • Force RFT thinking and approach
  • Considering EHS Requirements
  • CSV person of contact of the assigned system till the handover to the operation organization
  • Participate to the system impact assessment as CSV SME

Your Profile:

  • Minimum of 5+ years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects
  • EXperience In Management/ leading.
  • Significant experience in regulated pharmaceutical industry and/or engineering company with proven experience on planning CQV activities, leading large senior reports and high understanding/management of KPIs
  • Familiarity with biologics (mammalian, CGT) as well as chemical manufacturing technologies desirable
  • Proven management experience in an EMA / FDA regulated environmental
  • trong knowledge of ISPE GAMP5 and ASTM guidelines with proven experience on large and complex projects
  • Very good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation

#boodt