Position:  Sr. Computerized System Validation Analyst
Location:  Toronto, Ontario
Job Id:  1238
# of Openings:  1

Sr. Computerized System Validation Analyst -  Toronto, ON
 
Tilray is a federally licensed producer of medical cannabis. We are committed to setting the gold standard of care and excellence in our industry. We believe that commitment starts with a great work environment and benefits for our associates.
 
Looking to develop your career at the forefront of a rapidly expanding industry?
 
Reporting to the Manager, IT Business Applications, the Sr Validation Analyst ensures that all systems used to support GMP processes are appropriately validated and controlled. Responsibilities include participating as a project team member on computer system implementation projects, both at the site and global level, to assure that validation activities and life cycle methodology are incorporated and documented appropriately during and after the project in accordance with company standards and procedures. Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues.

Role and Responsibilities
  • Support the organization’s computer system validation (CSV) program
  • Updates Master Validation Plan (MVP) for Computerized Systems (as required)
  • Writing, review, and approval of Validation Policies, SOPs and Documentation
  • Maintain accurate validation documentation and files according to GxP retention and retrieval requirements for the system
  • Initiate and lead risk assessment, gap analysis, and deviation management associated with validation of computer systems
  • Coordinate validation activities with affected departments and project team members
  • Support IT with testing if required
  • Ensure the Systems Inventory is up to date at all times
  • Train other staff members on the correct use of computerized systems in line with protocols and regulations
  • Keep up to date with advances in the field and, in particular, the regulatory requirements
  • Assess all new systems and changes to systems for validation impact
  • Recommendation of process upgrades and improvements in efficiency
  • Implementation of such improvements
  • Involvement in both internal audits and external inspections as required
  • Complete periodic reviews of GxP computer systems with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state

Qualifications 

  • 5-8 years’ related CSV experience
  • Must have post-secondary school degree Computer Science, Information Systems or related field preferred
  • Significant experience with GAMP 5, FDA Regulations US FDA (21 CFR Part 11)
  • Experience with SDLC - System Development Life-cycle and/or program management in a GMP environment
  • Superior written and verbal communication skills
  • Superior writing skills as well strong accuracy and attention to detail
  • Detail oriented and organized, with a high degree of accuracy and thoroughness
  • Ability to multi-task, meeting tight deadlines in a fast paced environment
  • Ability to work independently with minimal supervision
  • Proficient PC skills; proven experience with MS Office – Word, Excel
  • This position may require occasional domestic and international travel
 

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