Computer System Validation Expert

1 week ago

Oakville, Ontario, Canada CB Canada Full time

About the Job


We are seeking an experienced Computer System Validation Specialist to join our team at AmerisourceBergen. As a key member of our validation team, you will be responsible for implementing our computer system validation strategy and leading validation efforts on computerized systems to support business systems with GxP impact.



About the Role


The ideal candidate will have a strong background in computer system validation and regulatory requirements, including ISPE GAMP5, 21 CFR part 11, Annex 11, and other harmonized international guidelines. You will be responsible for reviewing and developing validation strategies, preparing validation documentation packages, and managing all assigned computer validation projects.



Responsibilities



  2. Implement Innomar's computer system validation (CSV) strategy and lead validation efforts on computerized systems to support business systems with GxP impact.
  3. Review and/or develop validation strategies and associated documentation against the requirements of Innomar's CSV Policy and Procedures, as well as the Validation Master Plan (VMP).
  4. Prepare validation documentation packages, including development and execution of documentation for validation and qualification activities to support various computer system validation projects.
  5. Evaluate changes in validated computerized systems using a risk-based approach and assign appropriate levels of validation requirements.
  6. Effectively manage all assigned computer validation projects, enhancements, and requests for change (RFCs), including the review of high-level estimates (HLEs) from IT/PM to ensure QA timelines provided/forecasted are consistent with the expected project completion date.
  7. Provide guidance and/or support to other members of the validation team, including operational business units, IT, and 3rd party vendors, in the development of validation deliverables.
  8. As necessary, obtain and review Unit Test documentation from the IT development team/vendor to ensure the codes released to the test environment have been adequately unit-tested prior to QA validation activities.
  9. Manage defects/deviations/incidents in validation projects, including logging all defects/deviations/incidents identified during IQ, OQ & PQ, organizing defect/deviation/incident Triage Meetings with the required stakeholders, and maintaining and updating defect/deviation/incident log with appropriate status prior to closure of the project for filing.
  10. Coordinate and manage validation and qualification testing documentation review, approval signoff, execution, and post-execution review.
  11. Maintain computer system validation documentation and archiving, ensuring effective document retrieval when required.
  12. Coordinate with IT, QA, and applicable business units in the training of validation project team members on testing and validation policies, practices, and tools.
  13. Provide quality guidance and assessment to ensure maintenance of, and changes to, validated systems are managed in accordance with current corporate and regulatory requirements.
  14. Conduct QA audits of IT and validation processes as scheduled.
  15. Review and provide input, where required, to CSV-related Standard Operation Procedures (SOPs) and/or policies, and ensure adherence to internal SOP's and regulatory requirements.
  16. Keep current with relevant industry and regulatory guidelines.
  17. Coordinate and provide direct oversight of third-party vendors/partners for all software validation activities assigned.
  18. Flexibility to work overtime when required.
  19. Comply with all appropriate policies, procedures, and safety rules and regulations.
  20. Travel up to 10% of the time.
  21. Perform other related duties as assigned by QA management.


Requirements



  • A minimum of three (3) years hands-on experience in validation of GxP computerized systems and software development methodologies, preferably in the pharmaceutical, biotech, or medical device environment.
  • A college or university degree in computer sciences, business administration, or similar vocations.
  • Formal training in the field of computer sciences, business administration, or similar vocations.
  • Strong knowledge and understanding of computer system validation processes and regulatory requirements.
  • Ability to communicate effectively both orally and in writing.
  • Excellent teamwork and interpersonal skills.
  • Strong analytical, problem-solving, and conceptual skills.
  • Excellent organizational skills and attention to detail.
  • Ability to prioritize workload and consistently meet deadlines.
  • Practical understanding of project management principles and methodologies.
  • Experience in creation and review of Standard Operating Procedures (SOPs).
  • Experience in using automated enterprise testing tools.
  • Knowledge of relevant technology, tools, and software.

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