Validation Specialist

Job Location :

Canada
Billennium in Canada is currently seeking a candidate for the position of Validation Specialist to join the Team of 35 Validation Specialists spread around the globe, mainly Europe and Asia, working on the pharma industry projects involving validation in the field of clinical trials, safety, medical devices, integrations, ERP, and others. This position requires an Individual Contributor with a problem-solving mindset, open to working in a multicultural environment along with other stakeholders.        

Your role

  • Independently lead computer system validation
  • Lead risk assessments to determine validation strategy and testing scope
  • Work with internal and external customers to identify and implement improvements and validation optimization
  • Evaluate and perform periodic reviews of existing validated computer systems to verify continued compliance with appropriate regulations and maintain required change control procedures
  • Review/ approve computer system validation deliverables and summary reports
  • Provide technical assessment and validation review/ approval for process and standard operating procedure changes
  • Communicate proactively with stakeholders and management regarding progress, issues, and plans for resolution

Your skills & experience

  • Solid experience in SDLC and Computer Systems Validation (CSV)
  • Experience in software validation and compliance activities in Pharma environment
  • Experience working with GxP applications
  • Practice in creation/maintenance & implementation of SOPs
  • Know-how of cGMP, 21 CFR Part11 and GAMP 5
  • Know-how of FDA 21 CFR Part11, Annex 11 and GAMP 5
  • Thorough understanding of industry standards and best practices particularly as they relate to the operation, validation, and maintenance of computer-controlled systems
  • Practical experience with quality risk management and risk-based validation approaches
  • Strong technical writing, verbal communication, interpersonal and problem-solving skills
  • Ability to work independently, organize and manage individual as well as lead larger-scale projects
Join our team!
Join our team!

Recruiter Responsible for offer

Join our team!