Computer System Validation Specialist

1 month ago

Toronto, Ontario, Canada Innomar Strategies Full time
Job Title: Computer System Validation Specialist

At Innomar Strategies, we are seeking a highly skilled Computer System Validation Specialist to join our team. As a key member of our validation team, you will be responsible for ensuring the compliance of our computerized systems with regulatory requirements.

Key Responsibilities:
  • Develop and implement computer system validation strategies and lead validation efforts on computerized systems to support business systems with GxP impact.
  • Review and assist in developing validation strategies and associated documentation against the requirements of our CSV Policy and Procedures.
  • Prepare validation documentation packages, including development and execution of documentation for validation and qualification activities.
  • Evaluate changes in validated computerized systems using a risk-based approach and assign appropriate levels of validation requirements.
  • Effectively manage all assigned computer validation projects, enhancements, and requests for change.
  • Design and execute test cases and setup data for tests scripts that are appropriate to the risks and purpose of the applications and enhancements.
  • Provide guidance and support to other members of the validation team in the development of validation deliverables.
  • Manage defects, deviations, and incidents in validation projects, including logging, triage, and maintenance of defect/deviation/incident logs.
  • Coordinate and manage validation and qualification testing documentation review, approval, signoff, execution, and post-execution review.
  • Maintain computer system validation documentation and archiving ensuring effective document retrieval when required.
  • Coordinate with IT, QA, and applicable business units in the training of validation project team members on testing and validation policies, practices, and tools.
  • Provide quality guidance and assessment to ensure maintenance of, and changes to, validated systems are managed in accordance with current corporate and regulatory requirements.
  • Conduct QA audits of IT and validation processes as scheduled.
  • Review and provide input to CSV-related Standard Operation Procedures (SOPs) and/or policies, and ensure adherence to internal SOP's and regulatory requirements.
  • Keep current with relevant industry and regulatory guidelines.
  • Coordinate and provide direct oversight of third-party vendors/partners for all software validation activities assigned.
Requirements:
  • Minimum of three (3) years hands-on experience in validation of GxP computerized systems and software development methodologies.
  • College or university degree in computer sciences, business administration, or similar vocations.
  • Thorough knowledge and understanding of computer system validation processes and regulatory requirements, including ISPE GAMP5, 21 CFR part 11, Annex 11, and other harmonized international guidelines.
  • Ability to communicate effectively both orally and in writing.
  • Demonstrated understanding of quality assurance and quality systems principles.
  • Hands-on experience in validation of GxP systems and auditing of IT and validated systems.
  • Excellent teamwork and interpersonal skills; leadership and relationship building skills.
  • Strong analytical, problem-solving, and conceptual skills.
  • Excellent organizational skills; attention to detail.
  • Ability to resolve system issues effectively and efficiently.
  • 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) is desirable.
  • Experience in using automated enterprise testing tools is an asset.
What We Offer:

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness.

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