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Qualification & Validation Manager

Ref: JN-062021-181380

Publié le 07 September 2021
Sciences de la vie

Modis Life Sciences is looking for a one of it's clients a:

  • Responsible to maintain our global Validation Master Plan including: Equipment, Utilities,
  • and Premises Qualification, Computer System Validation, Process Validation
  • To establish risk assessment and to coordinate Change Control activities mainly for technical
  • and quality aspects for Equipment, Utilities and Premises.
  • Oversees validation of production processes, performs statistical analysis, develops
  • validation models, and writes process validation protocols and final packages.
  • Serves as liaison/team member with technical and production departments
  • Review and develop standard operating procedures in compliance with Good
  • Manufacturing Practice (GMP)

  • Technical Degree from a University, Engineering School or equivalent in Life Sciences, (e.g.
  • Pharmacy, Chemistry, engineering or related fields)
  • First and successful experience with validation and qualification activities. Aseptic
  • manufacturing knowledge is preferred.
  • Hands on with aseptic filling equipment and facilities, autoclaves, HVAC and WFI systems is
  • preferred
  • Good knowledge of GMP (US and Europe)
  • Working knowledge of Computer Validation and of statistics as related to process control.
  • Working understanding of Risk Analysis and Control
  • Experience with Deviations and CAPA management system (eg: Trackwise), Documentation
  • Management system, and SAP
  • Fluency in English and French is required for the role