Computer Validation Specialist
- Paris, ON | Full-time, Permanent
Aleafia Health is committed to being Canada’s leading patient-focused healthcare enterprise offering medical cannabis care. Our mission is to build a global cannabis brand. Through education, research, and development, we will advance the cultivation and science of medically authorized cannabis.
The Computer System Validation (CSV) Specialist is responsible for leading all validation efforts on computerized systems (hardware & software) to support business systems that have GxP impact, ensuring compliance with PIC/S Annex 11 and 21CFR11 requirements are established and maintained at all times. This includes prioritizing, executing, maintaining, and coordination of CSV activities, evaluation of software applications against design specifications and user requirements, and serves as the liaison between the appropriate IT, operational business units and external partners (where applicable) on validation activities, in order to ensure project expectations are properly set and met as per company policies and procedures. The CSV Specialist may occasionally support software/application testing.
- Review and/or assist in developing validation strategies and associated documentation against the requirements of Aleafia’s CSV Policy and Procedures, as well as the Validation Master Plan (VMP) to ensure that compliance and business needs are achieved.
- Prepare validation documentation packages, including development and execution of documentation for validation and qualification activities to support various computer system validation projects. Documents to be authored may include: Validation Plan, Requirements Trace Matrix, Risk Assessment, IQ/OQ/PQ Testing Protocols, Test Cases, Validation Summary Report, Change control, SOPs, etc.
- 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. Complete assigned projects and tasks within agreed deadlines.
- Evaluate changes in validated computerized systems using a risk-based approach and assign appropriate levels of validation requirements.
- Design/create and execute test cases (e.g., functional tests, integration tests, challenge tests, regression tests, etc.) 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 (including operational business units, IT and 3rd party vendors) in the development of validation deliverables, such as User Requirements Specifications (URS), 21CFR11/Annex 11 assessments, Functional Requirements Specification (FRS), Design Specifications, etc.
- As necessary and where applicable for validated systems, 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.
- Coordinate with IT, QA and applicable business units in the training of validation project team members on testing and validation policies, practices and tools. This may include formal preparation of training materials, one-on-one training, and classroom training.
- Provide quality guidance and assessment to ensure maintenance of, and changes to, validated systems are managed in accordance with current corporate and regulatory requirements.
- Co-ordinate validation and change control activities with the owners of the equipment/processes.
- Participate in Internal, Customer and Regulatory Audits.
- Keep current with industry and regulatory guidelines.
Experience / Education
- University degree in Business or Computer Science or equivalent experience.
- 2 - 3 years of working experience in a computer validation capacity preferably in the pharmaceutical or biotech environment.
- 2 years of project management.
- 2 years manufacturing experience, preferably in a pharmaceutical business environment.
- 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.
Skills & Abilities
- 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).
- 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 (SOP’s) is desirable.
Note: The chosen applicant will be required to successfully complete reference checks and a criminal background check.
We appreciate the interest by all candidates however we will be contacting those that best fit the requirements. Aleafia Health welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. If you are selected to participate in the recruitment process, please inform Human Resources of any accommodations you may require. Aleafia Health will work with you in an effort to ensure that you are able to fully participate in the process.