Quality Systems Specialist

4 weeks 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

  • Quality Systems Specialist

    3 weeks ago

    Laval, Quebec, Canada Bausch & Lomb Full time

    Bausch Health Canada is a leading 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.Our IT DepartmentThe IT Specialist Quality Systems will...

  • Software Quality Assurance and Automation Specialist

    2 weeks ago

    Laval, Quebec, Canada FLIR Systems, Inc. Full time

    Transform Your Career as a Software Test and Validation ExpertWe are seeking an exceptional Software Test and Validation Specialist to join our Engineering team at FLIR Systems, Inc. in Laval, Quebec.This role is ideal for individuals who excel in making a lasting impact and thrive in fast-paced environments.About the RoleAs a member of our software and...

  • RF System Specialist

    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 System Specialist

    2 weeks ago

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

    About FLIR Unmanned Aerial Systems, ULCAs a technology leader in the defense industry, FLIR Unmanned Aerial Systems, ULC, is committed to delivering innovative solutions that safeguard lives and protect national interests.Our team is comprised of passionate innovators who are dedicated to pushing the boundaries of what is possible in radar technology.Job...

  • Quality Assurance Specialist

    1 week ago

    Laval, Quebec, Canada Solution SFT Full time

    Job DescriptionSolution SFT is seeking a highly skilled Quality Assurance Specialist to join our team. This role will be responsible for ensuring that customer rating and quality performance are collected, monitored, analyzed, and reported periodically.This position requires a strong understanding of statistical process control and document management...

  • Quality Assurance Specialist

    2 weeks ago

    Laval, Quebec, Canada Solutionsft Full time

    **Job Summary**As a Quality Assurance Specialist at Solutionsft, you will be responsible for tracking and reporting customer rating and quality performance metrics. You will analyze data using Statistical Process Control (SPC) techniques and ensure that production and staff personnel have the necessary product criteria and routers to perform their...

  • Database Systems Specialist

    4 weeks ago

    Laval, Quebec, Canada Ardene Full time

    We are seeking a skilled Database Systems Specialist to play a key role in the success of our team at Ardene.About the Role:The Database Systems Specialist will be responsible for installing and configuring database management systems (DBMS) and related tools. This includes implementing and maintaining database security measures to safeguard sensitive...

  • Pharmaceutical Systems Compliance Specialist

    13 hours ago

    Laval, Quebec, Canada Bausch & Lomb Full time

    Bausch Health Canada is a leading international pharmaceutical company dedicated to providing 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.We invest in our employees and believe in...

  • Technical Support Specialist for Renewable Energy Systems

    4 weeks ago

    Laval, Quebec, Canada Volts Energies Full time

    Job Title: Technical Support Specialist for Renewable Energy SystemsAbout the Company: Volts Energies is a pioneer in the field of renewable energy, dedicated to offering sustainable and innovative energy solutions.Job Description: We are seeking an experienced Technical Support Specialist to provide high-quality support and rapid resolution of technical...

  • Quality Assurance Specialist

    1 month ago

    Laval, Quebec, Canada Bausch & Lomb Full time

    Bausch Health Canada is a leading 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 Expert, you will design and deliver...

  • Senior Quality Assurance Specialist

    1 week ago

    Laval, Quebec, Canada Fourgons TRANSIT Truck Bodies Full time

    Company OverviewMorgan Transit is a family-owned business founded in 1978, offering permanent employment in a rapidly growing company with year-round job stability.We provide competitive compensation with the first salary review after 3 months, evening shift premium of $2.15/hour, and comprehensive group insurance program including telemedicine.Job...

  • Refrigeration Systems Support Specialist

    1 week ago

    Laval, Quebec, Canada Vertex Full time

    At Vertex, we are seeking a skilled Refrigeration Systems Support Specialist to join our team.We offer an attractive salary between $62,500 and $92,500 based on experience, reflecting the company's commitment to fair compensation.Job Description:The successful candidate will provide remote technical support for refrigeration systems, utilizing their...

  • Electronics Engineer

    1 week ago

    Laval, Quebec, Canada AMETEK Full time

    Job OverviewCreaform Ingénierie is seeking a highly skilled Electronics Engineer to join our team as a System Design Specialist. As a key member of our engineering department, you will be responsible for designing and developing electronic systems from definition to production.About the RoleThe ideal candidate will have a strong background in...

  • HVAC Systems Specialist

    4 weeks ago

    Laval, Quebec, Canada Navada Full time

    ### Company OverviewNavada is a 100% Quebecois company proudly representing a winning equation for over 50 years. As a refrigeration expert, you'll become one of our ambassadors, contributing to our reputation among clients and employees alike.### Salary RangeThe estimated salary for this position is $60,000 - $80,000 per year, depending on experience and...

  • Plumbing Specialist

    2 weeks ago

    Laval, Quebec, Canada Plomberie Capitaine Full time

    About the JobWe are seeking a skilled Plumbing Specialist to join our team at Plomberie Capitaine. In this role, you will be responsible for installing, maintaining, and repairing domestic, commercial, or industrial plumbing fixtures and systems.Key ResponsibilitiesInstall piping systems, fixtures, and equipment in accordance with local building codes and...

  • Financial Performance 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 distributes a wide range of pharmaceuticals and health products across the country.We are seeking a Financial Performance Specialist based in Laval, Quebec, offering a hybrid work...

  • Electrical Design Specialist

    3 weeks ago

    Laval, Quebec, Canada AMETEK Full time

    Electrical Design Specialist OpportunityWe are seeking an Electrical Design Specialist to join our team at Creaform Engineering, a business unit of AMETEK Inc. In this role, you will participate in the design and development of electrical systems for various industries, including transportation, motorsports, aerospace, technology, defense, and energy.Key...

  • Hair Design Specialist

    4 weeks ago

    Laval, Quebec, Canada Regis Canada Full time

    About This Role: We are looking for a talented Hair Design Specialist to join our team at Regis Canada. As a Hair Design Specialist, you will be responsible for providing exceptional guest service, understanding your guests' needs, and delivering quality consultations and services.Key Responsibilities:Guest Service: Provide exceptional guest service,...

  • Inventory Control Specialist

    2 weeks ago

    Laval, Quebec, Canada AIM Delsan Full time

    Job DescriptionWe are seeking a highly organized and detail-oriented Inventory Control Specialist to join our team at AIM Delsan.Key Responsibilities:Goods Receipt: Ensure the receipt of merchandise and verify the quantities and quality of orders.Inventory Management: Maintain accurate records of inventory levels and conduct cycle counts to ensure...

  • Software Validation and Automation Specialist

    2 weeks ago

    Laval, Quebec, Canada Teledyne FLIR Full time

    Teledyne FLIR is a leading provider of innovative sensing solutions for industrial growth markets. We offer advanced technology and high-reliability products that enable our customers to achieve their goals.Salary Information:We offer a competitive salary for this position, estimated to be in the range of $85,000 - $110,000 per year, depending on...