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Computer System Validation Specialist

2 months ago

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

We are seeking a highly skilled Computer System Validation Specialist to join our team at Innomar Strategies. 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, as well as the Validation Master Plan (VMP).
  • Prepare validation documentation packages, including development and execution of documentation for validation and qualification activities to support various computer system validation projects.
  • 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 (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.
  • Design/create 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/or support to other members of the validation team in the development of validation deliverables, such as User Requirements Specifications (URS), 21CFR11/Annex 11 assessments, Functional Requirements Specification (FRS), Design Specifications, etc.
  • Manage defects/deviations/incidents in validation projects, including logging, triage meetings, and maintaining and updating defect/deviation/incident log with appropriate status prior to closure of the project.
  • 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.
  • Flexibility to work overtime when required.
  • Comply with all appropriate policies, procedures, and safety rules and regulations.
  • Travel up to 10% of the time.
Requirements:
  • Requires 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 with extensive experience in a matrixed environment and interactions with external vendors.
  • A college or university degree in computer sciences (e.g., IT, information security, engineering, software programming, etc.) is required.
  • Requires formal training in the field of computer sciences, business administration, or similar vocations generally obtained through completion of a four-year Bachelor's Degree program, technical vocational training, or equivalent combination of experience and education.
  • Requires a 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 (PIC/S, ICH) and GxP.
  • Ability to communicate effectively both orally and in writing is a must.
  • Demonstrated understanding of quality assurance and quality systems principles (training documentation, change control, validation, vendor management, and audits).
  • Hands-on experience in validation of GxP systems is required.
  • Experience in auditing of IT and validated systems are required.
  • 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 in order to support and assist company's testing initiatives.
  • Experience with one of the following testing tools is an asset: Quality Center, LOADRUNNER, or QUICKTEST PRO.
  • Working knowledge of relevant technology, tools, and software; knowledge of UNIX, SDLC, Desktop services, HP Test tools, or equivalent testing tools.
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. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.