Quality Systems Specialist

1 week ago

Laval, Quebec, Canada Bausch & Lomb Full time

Bausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide variety of pharmaceutical and health products distributed in pharmacies, healthcare practices, and hospitals across the country.

As an IT Validation and Compliance Expert, you will design and deliver documentation for IT systems to fulfill pharma-related legal requirements. You will help develop validation strategies, documentation, and ensure compliance during configuration, implementation, testing, and maintenance of validated status consistent with quality policies and procedures.

This position is closely aligned with the Global Validation leadership and contributes to educating and deploying common practices across regions. As a complementary activity, you will contribute to change management activities according to priorities and availability related to required validation work.

Scope and Core Responsibilities

  1. Providing validation services for IT solutions:
    1. Determining the scope of validation and required documentation
    2. Approval and administration of validation documentation, including SOPs, acceptance criteria, plans, and reports required for validated systems
    3. Performing functional analysis and risk assessment
  2. Contribution to change management activities in line with priorities and availability related to validation work:
    1. Checking whether the change does not affect the system state
    2. Determining the impact of the computer system on the GxP process and making a preliminary risk assessment for the computer system
    3. Ensuring compliance of the entire testing process, including the description of the development and testing environment, with the change request form
    4. Releasing the change in test and production environments, performing a final review before closing the change
  3. Carrying out the qualification of IT suppliers
  4. Ensuring compliance with internal policies and procedures as well as external regulations:
    1. Cooperation in the implementation of the CSV framework and the validation process based on GAMP 5 (Good Automated Manufacturing Practice)
    2. Development and training interested business and IT team members on IT validation procedures, in line with the global validation direction
    3. Ensuring consistency of validation processes across regions in close collaboration with Corporate IT Validation leadership
  5. Collaboration with external service providers managing system changes and/or managing validation activities
  6. Cooperation between departments in the areas of quality, IT, logistics, and production
  7. Support for internal and external audits of IT systems and applications:
    1. Primary point of contact for IT in all internal and external audit teams where an IT inquiry is required
    2. Identification of observations and management of corrective actions
    3. Collaboration with management and business to implement solutions
    4. Deviation tracking for GxP systems, defining CAPA

Experience and Skill Sets Preferred

The ideal candidate is well-experienced with IT systems validation, with deep knowledge and understanding of the following areas:

  • Knowledge of GAMP 5, Annexes 11 and 15 of the EU GMP, and FDA Part
  • Experience on validation and audits on GxP IT systems
  • Knowledge of IT technologies related to production and distribution processes in the pharmaceutical industry
  • Excellent communication skills with the ability to work at all levels
  • Experience working with different cultures
  • Project coordination skills
  • Positive attitude and longing for results are essential qualities
  • Analytical and creative, able to offer new ideas and perspectives to the situation
  • Flexible approach to working hours and location
  • Ability to work as part of a dispersed team but also self-motivated
  • Broad experience of IT solutions
  • Ability to perform and conduct workshops and meetings to develop solutions
  • Fluent in French and English

  • RF System Specialist

    2 months ago

    Laval, Quebec, Canada FLIR Unmanned Aerial Systems, ULC Full time

    About FLIR Unmanned Aerial Systems, ULCWe are a leading provider of advanced sensing and threat detection technologies, dedicated to safeguarding lives and protecting our customers' interests.Job Summary:As an RF System Specialist at FLIR Unmanned Aerial Systems, ULC, you will play a critical role in the design, qualification, and production of...

  • RF System Specialist

    2 months ago

    Laval, Quebec, Canada FLIR Unmanned Aerial Systems, ULC Full time

    About FLIR Unmanned Aerial Systems, ULCWe are a leading provider of advanced sensing and threat detection technologies, dedicated to safeguarding lives and protecting our customers' interests.Job Summary:As an RF System Specialist at FLIR Unmanned Aerial Systems, ULC, you will play a critical role in the design, qualification, and production of...

  • RF System Specialist

    2 weeks ago

    Laval, Quebec, Canada FLIR Unmanned Aerial Systems, ULC Full time

    About FLIR Unmanned Aerial Systems, ULCWe're dedicated to developing cutting-edge sensing and threat detection technologies that safeguard lives. Our advanced surveillance sensors, handheld devices, unmanned vehicles, lasers, and more solutions increase operational effectiveness for warfighters, first responders, and search-and-rescue teams.Job Summary:At...

  • Quality Assurance Specialist

    3 weeks ago

    Laval, Quebec, Canada Bausch & Lomb Full time

    Job Title: Quality Systems SpecialistBausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Job SummaryWe are seeking a highly skilled Quality Systems...

  • Quality Assurance Specialist

    3 weeks ago

    Laval, Quebec, Canada Bausch & Lomb Full time

    Job Title: Quality Systems SpecialistBausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Job SummaryWe are seeking a highly skilled Quality Systems...

  • Quality Assurance Specialist

    1 month ago

    Laval, Quebec, Canada Bausch & Lomb Full time

    Job Title: Quality Systems SpecialistBausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Job SummaryWe are seeking a highly skilled Quality Systems...

  • Quality Assurance Specialist

    4 weeks ago

    Laval, Quebec, Canada Bausch & Lomb Full time

    Job Title: Quality Systems SpecialistBausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Job SummaryWe are seeking a highly skilled Quality Systems...

  • Quality Assurance Specialist

    4 weeks ago

    Laval, Quebec, Canada Bausch & Lomb Full time

    Job Title: Quality Systems SpecialistBausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Job SummaryWe are seeking a highly skilled Quality Systems...

  • Quality Assurance Specialist

    4 weeks ago

    Laval, Quebec, Canada Bausch & Lomb Full time

    Job Title: Quality Systems SpecialistBausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Job SummaryWe are seeking a highly skilled Quality Systems...

  • Quality Assurance Specialist

    4 weeks ago

    Laval, Quebec, Canada Bausch & Lomb Full time

    Job Title: Quality Systems SpecialistBausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Job SummaryWe are seeking a highly skilled Quality Systems...

  • Quality Assurance Specialist

    4 weeks ago

    Laval, Quebec, Canada Bausch & Lomb Full time

    Job Title: Quality Systems SpecialistBausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Job SummaryWe are seeking a highly skilled Quality Systems...

  • Quality Assurance Specialist

    2 weeks ago

    Laval, Quebec, Canada Bausch & Lomb Full time

    Job Title: Quality Systems SpecialistBausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Job SummaryWe are seeking a highly skilled Quality Systems...

  • Quality Assurance Specialist

    2 weeks ago

    Laval, Quebec, Canada Bausch & Lomb Full time

    Job Title: Quality Systems SpecialistBausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Job SummaryWe are seeking a highly skilled Quality Systems...

  • RF Systems Engineer

    2 months ago

    Laval, Quebec, Canada FLIR Unmanned Aerial Systems, ULC Full time

    About FLIR Unmanned Aerial Systems, ULCWe're a leading provider of advanced sensing and threat detection technologies, dedicated to safeguarding lives and increasing operational effectiveness for warfighters, first responders, and search-and-rescue teams.Job Summary:As an RF Specialist, you'll work on the design, qualification, and production of...

  • RF Systems Engineer

    2 months ago

    Laval, Quebec, Canada FLIR Unmanned Aerial Systems, ULC Full time

    About FLIR Unmanned Aerial Systems, ULCWe're a leading provider of advanced sensing and threat detection technologies, dedicated to safeguarding lives and increasing operational effectiveness for warfighters, first responders, and search-and-rescue teams.Job Summary:As an RF Specialist, you'll work on the design, qualification, and production of...

  • RF Systems Engineer

    1 month ago

    Laval, Quebec, Canada FLIR Unmanned Aerial Systems, ULC Full time

    About FLIR Unmanned Aerial Systems, ULCWe're dedicated to developing cutting-edge sensing and threat detection technologies that safeguard lives. Our advanced surveillance sensors, handheld devices, unmanned vehicles, lasers, and more solutions increase operational effectiveness for warfighters, first responders, and search-and-rescue teams.Job Summary:At...

  • RF Systems Engineer

    1 month ago

    Laval, Quebec, Canada FLIR Unmanned Aerial Systems, ULC Full time

    About FLIR Unmanned Aerial Systems, ULCWe're dedicated to developing cutting-edge sensing and threat detection technologies that safeguard lives. Our advanced surveillance sensors, handheld devices, unmanned vehicles, lasers, and more solutions increase operational effectiveness for warfighters, first responders, and search-and-rescue teams.Job Summary:At...

  • Electrician - Photovoltaic Systems Specialist

    2 months ago

    Laval, Quebec, Canada VINCI Energies en France Full time

    About the Role:We are seeking a skilled Electrician - Photovoltaic Systems Specialist to join our team at VINCI Energies in France. As a key member of our team, you will be responsible for designing, installing, and maintaining photovoltaic systems for our clients.Key Responsibilities:Design and install photovoltaic systems for commercial and industrial...

  • Electrician - Photovoltaic Systems Specialist

    2 months ago

    Laval, Quebec, Canada VINCI Energies en France Full time

    About the Role:We are seeking a skilled Electrician - Photovoltaic Systems Specialist to join our team at VINCI Energies in France. As a key member of our team, you will be responsible for designing, installing, and maintaining photovoltaic systems for our clients.Key Responsibilities:Design and install photovoltaic systems for commercial and industrial...

  • Aviation Quality Assurance Specialist

    1 month ago

    Laval, Quebec, Canada M1 Composites Technology Inc. Full time

    About M1 Composites Technology Inc.M1 Composites Technology Inc. is a leading provider of composite and sheet metal structures for the commercial and defense aviation industry. Our team of experts has a unique opportunity to work on a wide range of aircraft types, giving them a chance to develop their skills and expertise.Job SummaryWe are seeking a highly...