Validation Specialist

3 weeks ago

Canada Tekgence Inc Full time

Job Title: Qualification Specialist – Equipment Integration Location: Remote Contract-12+ Months Someone who has experience in the below skills from Scratch Validation Master Plan PI Historian System Qualification Specialist - Hardware and Software in GMP Setting As Qualification Specialist in the Equipment Integration team, you are responsible for caring about the GMP requirements. The team is responsible for transferring existing Lab Equipment form Spark Network to Roche Connect Network (RCN). Including replacing the HW, OS and renew the application including the configuration and data. Your work requires you to actively interface with equipment owners, product/project managers, and business stakeholders to design and develop the build, release, and deploy for digital solutions. Responsibilities involve ensuring that our digital solutions meet regulatory requirements and quality standards, including qualified equipment, partially connected to validated software, and processes to ensure they perform as intended and comply with regulations. Excellent communication skills and teamwork are a must. Responsibilities: ● Qualification Strategy: Develop and implement a qualification strategy for digital equipment, ensuring alignment with regulatory requirements, industry best practices, and Roches internal standards. ● Qualification Plans and Protocols: Create qualification plans and protocols for equipment that will be connected to RCN including their interfaces and automation applications. Ensure that all qualification activities are properly documented and executed according to established procedures. ● Risk Assessment: Conduct risk assessments to identify potential risks associated with the use of digital solutions in a GMP environment. Develop risk mitigation strategies and ensure that appropriate controls are in place. ● Testing and Qualification: Collaborate with cross-functional teams to perform testing and qualification activities for digital solutions, particularly with QA SMEs. This includes executing test cases, analyzing results, and documenting findings. ● Compliance and Documentation: Ensure that all qualification activities are compliant with relevant regulatory requirements, such as GMP and data integrity guidelines. Maintain accurate and up-to-date validation documentation, including validation plans, protocols, reports, and change control documentation. ● Continuous Improvement: Drive continuous improvement initiatives related to qualification processes, tools, and methodologies. Stay updated with the latest industry trends and regulatory requirements in the field of validation. ● Communication and stakeholder management: Act as an interface between business and IT functionals and as a contact point for business leads in order to launch initiatives, leading and driving the scoping phase. Candidate requirements: ● Understanding of lab systems lifecycle models and experience with business/end-user applications. ● Strong knowledge in qualification principles and practices in a GMP environment. Experience in qualification of digital solutions, including Release Management processes and controls. ● Experience in managing infrastructure through multiple product releases.

  • Validation Specialist

    3 weeks ago

    Canada Tekgence Inc Full time

    Job Title: Qualification Specialist – Equipment Integration Location: Remote Contract-12+ Months Someone who has experience in the below skills from Scratch Validation Master Plan PI Historian System Qualification Specialist - Hardware and Software in GMP Setting As Qualification Specialist in the Equipment Integration team, you are responsible for caring...

  • Validation Specialist

    3 weeks ago

    Canada Tekgence Inc Full time

    Job Title: Qualification Specialist – Equipment Integration Location: Remote Contract-12+ Months Someone who has experience in the below skills from Scratch - Validation Master Plan - PI Historian System Qualification Specialist - Hardware and Software in GMP Setting As Qualification Specialist in the Equipment Integration team, you are responsible...

  • Specialist, Validation

    1 week ago

    Canada Sun Pharmaceutical Industries - Full time

    Job purposeThe Validation Specialist is responsible to lead validation activities and provide expertise for the generation, execution, modification and summation of Validation documents of equipment (manufacturing and laboratory), processes, cleaning, sanitizing and facilities aspects of SunPharma Canada's manufacturing site that may affect the quality of...

  • Remote Content Validation Specialist

    2 weeks ago

    , , Canada Mercor Full time

    Remote Content Validation Specialist 2 days ago Be among the first 25 applicants This range is provided by Mercor. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $35.00/hr - $35.00/hr Direct message the job poster from Mercor About The Job Mercor connects elite creative and technical...

  • Specialist- Verification and Validation

    2 weeks ago

    Canada CAE Inc. Full time

    **Role and Responsibilities** CAE Healthcare is a division of CAE Inc. and a medical simulation company dedicated to improving healthcare training and patient safety. We design and manufacture products used for patient simulation, surgical simulation, ultrasound simulation, and clinical simulation management. **The role we are offering you**: **Duties and...

  • Remote AI Content Quality Validator

    2 weeks ago

    , , Canada Mercor Full time

    A technology consulting firm is looking for a Remote Content Validation Specialist to validate AI prompt responses, ensuring accuracy and clarity. You will work independently, providing valuable feedback to improve data quality. The ideal candidate will possess strong attention to detail and exceptional written communication skills. The role is part-time,...

  • Generative AI Scientist II: Model Validation

    4 weeks ago

    , , Canada TD Full time

    A financial institution in Toronto seeks an AI/ML Model Validation Specialist. The role involves validating Generative AI and Deep Learning models, developing validation methodologies, and communicating insights to various stakeholders. Candidates should have strong quantitative skills, an advanced degree in a relevant field, and experience with AI/ML...

  • Remote Baseball Analytics Annotator

    2 weeks ago

    , , Canada Mercor Full time

    A leading tech company is seeking a Baseball Analytics Data Annotation Specialist for a part-time, remote role. The specialist will review AI-generated baseball video annotations and ensure the accuracy of the labeling and validation of plays. Candidates must have a deep understanding of baseball and the ability to work independently on remote platforms....

  • Infrastructure Specialist

    3 weeks ago

    , , Canada Orion Innovation Full time

    Role: Infrastructure/Security Specialist Type: Remote working EST Hours Must be Eligible for Top Secret Security Clearance Job Description The company is seeking an experienced Infrastructure/Security Specialist. In this role, you will be responsible for designing, implementing, and maintaining the organization's infrastructure and security systems. You will...

  • Environmental Project Specialist

    6 days ago

    Canada Minnow Environmental, a Trinity Consultants Canada Team Full time

    Senior Environmental Permitting Specialist Minnow Environmental Inc. (Minnow), a Trinity Consultants Company, is a leader in environmental consulting services, providing aquatic, geoscientific, permitting, and environmental services to the mining sector across Canada. We are a firm of environmental scientists and engineers with multi-disciplinary expertise...