IT Systems Validation Expert

3 weeks ago


Montreal, Quebec, Canada Pharmascience Inc. Full time

Pharmascience Inc., a prominent leader in the generic pharmaceuticals sector since 1983, prides itself on its commitment to quality and the human touch in its operations. Our dynamic work environment fosters trust, collaboration, and a dedication to excellence. We invite you to explore a career with us.

The IT Systems Validation Expert plays a crucial role in overseeing the validation processes for Pharmascience's computerized systems.

Key Responsibilities:

  • Coordinate and prepare the development of IT Computerized GxP System Validation and Infrastructure Qualification documentation.
  • Conduct Impact and Risk Assessments for Computerized Systems in accordance with GAMP 5 guidelines.
  • Develop, review, and assist in the creation of validation documentation, including Validation Plans, User Requirement Specifications (URS), and various validation protocols.
  • Advise IT and Project Teams on validation strategies, methodologies, and testing procedures.
  • Engage in System Periodic Reviews and System Retirement processes.
  • Ensure compliance of new and existing IT Computerized GxP Systems with relevant regulations, including those from Health Canada and the US FDA.
  • Validate infrastructure components to ensure their qualification.
  • Assess IT Change Controls for impact, ensuring proper documentation, testing, and approval to maintain system validation.
  • Provide training on IT Computer System Validation procedures and regulatory requirements to Project Teams.
  • Participate in the evaluation and qualification of IT suppliers and vendors.
  • Contribute to internal and external audits to ensure IT compliance with regulatory standards and internal policies.
  • Develop and maintain IT Standard Operating Procedures (SOPs) and training materials.
  • Propose enhancements to validation and qualification processes.
  • Stay informed about current Good Manufacturing Practices (GMP), Quality, and Compliance policies relevant to the IT Department.

Required Skills and Qualifications:

  • In-depth knowledge of Health Canada regulations, GAMP 5, CFR 21 Part 11, and current Good Manufacturing Practices.
  • Proficient in executing validation strategies for IT Computerized Systems.
  • Adept at analyzing requirements, assessing risks, and determining compliance evidence necessary for regulatory adherence.
  • Strong planning, prioritization, and analytical skills with the ability to manage multiple projects simultaneously.
  • Excellent judgment regarding compliance and risk management.
  • Strong organizational, problem-solving, and decision-making capabilities.

Education:

Bachelor's degree in Computer Science or a related field is required.

Experience:

A minimum of 5 to 10 years of experience in a GxP environment, preferably within the pharmaceutical industry, with a solid understanding of relevant regulations.



  • Montreal, Quebec, Canada Pharmascience Inc. Full time

    Since its inception in 1983, Pharmascience Inc. has established itself as a prominent player in the generic pharmaceuticals sector. Our Canadian roots extend globally, emphasizing the importance of personal connections in our operations. We foster a dynamic work environment characterized by trust, collaboration, and a commitment to excellence. We invite you...


  • Montreal, Quebec, Canada Pharmascience Inc. Full time

    Role OverviewThe Computer Systems Validation Expert is responsible for overseeing the validation processes of Pharmascience's computerized systems.Key ResponsibilitiesConduct Impact and Risk Assessments for Computerized Systems in accordance with GAMP 5 standards.Develop and maintain Validation Plans, User Requirement Specifications (URS), Specifications,...


  • Montreal, Quebec, Canada Pharmascience Full time

    Job Description**Computer Systems Validation Specialist**The Computer Systems Validation Specialist plays a crucial role in ensuring the integrity and compliance of Pharmascience's computer systems. This position is responsible for guiding the validation process, performing impact and risk assessments, and providing guidance on validation strategies and...


  • Montreal, Quebec, Canada Pharmascience Full time

    Job Description**Computer Systems Validation Specialist**The Computer Systems Validation Specialist plays a crucial role in ensuring the integrity and compliance of Pharmascience's computer systems. This position is responsible for guiding the validation process, performing impact and risk assessments, and providing guidance on validation strategies and...


  • Montreal, Quebec, Canada Pharmascience Full time

    About PharmasciencePharmascience is a leading generic drug company with a global presence. We pride ourselves on our commitment to quality and compliance, and we're looking for a skilled professional to join our team.Job SummaryWe're seeking a highly experienced Computer Systems Validation Specialist to guide the validation of our computer systems. This is a...


  • Montreal, Quebec, Canada Pharmascience Full time

    About PharmasciencePharmascience is a leading generic drug company with a global presence. We pride ourselves on our commitment to quality and compliance, and we're looking for a skilled professional to join our team.Job SummaryWe're seeking a highly experienced Computer Systems Validation Specialist to guide the validation of our computer systems. This is a...


  • Montreal, Quebec, Canada Senseability Full time

    SenseabilityValidation Engineer SpecialistAs a leading entity in the healthcare sector, Senseability is committed to enhancing patient outcomes through innovative solutions and services.Key Responsibilities:Oversee and execute all stages of assigned qualification and validation initiatives.Ensure adherence to regulatory standards and internal compliance...


  • Montreal, Quebec, Canada Fed IT Full time

    We are FED IT, a recruitment agency specializing in IT professions. Our team of experts works with companies to find the best IT talent for their needs.Our Recruitment Services:Temporary Recruitment: We provide temporary IT staff to help companies with short-term projects or to cover absences.Permanent Recruitment: We help companies find and hire permanent...


  • Montreal, Quebec, Canada Fed IT Full time

    We are Fed IT, a recruitment agency specializing in IT professions. Our team of IT experts works closely with clients to understand their IT needs and provides temporary and permanent recruitment solutions.As a recruitment and business development consultant at Fed IT, you will be responsible for:Identifying and attracting top IT talentBuilding and...


  • Montreal, Quebec, Canada Fed IT Full time

    We are Fed IT, a recruitment agency specializing in IT professions. Our team of IT experts works closely with clients to understand their IT needs and provides temporary and permanent recruitment solutions.As a recruitment and business development consultant at Fed IT, you will be responsible for:Identifying and attracting top IT talentBuilding and...


  • Montreal, Quebec, Canada Pharmascience Inc. Full time

    Job SummaryWe are seeking a highly skilled Senior Validation Specialist, Equipment and Systems to join our team at Pharmascience Inc.Key ResponsibilitiesDevelop and execute validation protocols for complex equipment and systemsManage validation projects from start to finish, ensuring compliance with regulatory requirementsCoordinate with cross-functional...


  • Montreal, Quebec, Canada Pharmascience Inc. Full time

    Job SummaryWe are seeking a highly skilled Senior Validation Specialist, Equipment and Systems to join our team at Pharmascience Inc.Key ResponsibilitiesDevelop and execute validation protocols for complex equipment and systemsManage validation projects from start to finish, ensuring compliance with regulatory requirementsCoordinate with cross-functional...


  • Montreal, Quebec, Canada Pharmascience Full time

    The Equipment and Systems Validation Specialist plays a crucial role in the validation of complex equipment and systems at Pharmascience. As a key team member, they collaborate with other validation team members on various projects, ensuring seamless execution and adherence to standard procedures.Key ResponsibilitiesDevelop and execute validation protocols...


  • Montreal, Quebec, Canada Pharmascience Full time

    The Equipment and Systems Validation Specialist plays a crucial role in the validation of complex equipment and systems at Pharmascience. As a key team member, they collaborate with other validation team members on various projects, ensuring seamless execution and adherence to standard procedures.Key ResponsibilitiesDevelop and execute validation protocols...


  • Montreal, Quebec, Canada Fed IT Full time

    Job Title: Network and Cybersecurity ExpertAre you a seasoned IT professional looking for a new challenge? Do you have a passion for network administration and cybersecurity? We are seeking a highly skilled Network and Cybersecurity Expert to join our team at Fed IT.Job Summary:We are looking for a talented individual to administer our company's Microsoft...


  • Montreal, Quebec, Canada Fed IT Full time

    Job Title: Network and Cybersecurity ExpertAre you a seasoned IT professional looking for a new challenge? Do you have a passion for network administration and cybersecurity? We are seeking a highly skilled Network and Cybersecurity Expert to join our team at Fed IT.Job Summary:We are looking for a talented individual to administer our company's Microsoft...


  • Montreal, Quebec, Canada Crédit Agricole Group Full time

    About the Role:We are seeking a highly skilled Senior Compliance Analyst to join our team at Crédit Agricole Group. As a key member of our compliance team, you will be responsible for ensuring that our financial models and systems are in line with regulatory requirements.Key Responsibilities:Articulate Complex Concepts: Develop and present clear and concise...


  • Montreal, Quebec, Canada Crédit Agricole Group Full time

    About the Role:We are seeking a highly skilled Senior Compliance Analyst to join our team at Crédit Agricole Group. As a key member of our compliance team, you will be responsible for ensuring that our financial models and systems are in line with regulatory requirements.Key Responsibilities:Articulate Complex Concepts: Develop and present clear and concise...

  • Test Expert

    4 days ago


    Montreal, Quebec, Canada CAE Full time

    About the RoleWe are seeking a highly skilled Test Expert to join our team at CAE. As a Test Expert, you will play a critical role in ensuring the quality and reliability of our synthetic training devices.Key ResponsibilitiesDevelop and execute verification and validation plans for our training devices.Conduct thorough testing and analysis to ensure...

  • Test Expert

    3 days ago


    Montreal, Quebec, Canada CAE Full time

    About the RoleWe are seeking a highly skilled Test Expert to join our team at CAE. As a Test Expert, you will play a critical role in ensuring the quality and reliability of our synthetic training devices.Key ResponsibilitiesDevelop and execute verification and validation plans for our training devices.Conduct thorough testing and analysis to ensure...